Pharmacovigilance Scientist
MIDClinical DevelopmentNeurology
$150K - $185K/yr(estimated)
Description
<p><span data-contrast="none">Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at </span><a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D9IV8MzSvfOHVeWvrQ7Gpyyjf8oh2YbOImEae8XHfJeeKdWb5iMTG_i6gTGCiHtoMzE1iVTUEQk7IBNDvtrd8dbwJfMAYLK1NiNGH8FOf8LVClDRvtC2QLJLwxcJsj8r1Ife70mjBMpRU8D5q5PfAvDP5AbMwldlIcg5842srmwDavyrAg8tK_VpiNRaKqPlOSPLrCg1Yr2Gqdo5K6iwgZGVlm_WvFI8bMuPXMrqlgRQ%3D&amp;data=05%7C02%7Cmsiegel%40axsome.com%7Cb0ad9a0787784e7305e308dda9c74deb%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C638853395639171980%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=dWf%2FLVmCejjY3pM4XQok9nH8pF%2BfGwqWCZ8QwdWpTGQ%3D&amp;reserved=0"><strong><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">www.axsome.com</span></span></strong></a><span data-contrast="none"> and follow us on </span><a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DgkOAMVaudmIbjNO4LWBtZ25_8dkwL1L91EK22smznktgIMuoh5PltUd03J1ZN68KtUufEmLQRMgUjKqoa2Pb1ADSKI0zgay-rDcXd0R2wsbi9WIetngm8x8P1QX9OxhZQzuoPJMXr0UXnyGnIAbSvjwOT0oODGh2y6eODJbInNknBhQ4fXiSCd0LwP8PlS9T_Er2Q-RAoqsN_pVSx0k80cO9ivcvtqdJxZGSzZ37Ytmfmq-AThjSdP9ltWSUa2Fx&amp;data=05%7C02%7Cmsiegel%40axsome.com%7Cb0ad9a0787784e7305e308dda9c74deb%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C638853395639206174%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=ZofAOfLit%2FDztSC9U2W1xpx9HHF9z5bb4r1JDK9%2FVzo%3D&amp;reserved=0"><strong><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">LinkedIn</span></span></strong></a><span data-contrast="none"> and </span><a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DU4SjZsngAmgWDPNMBXhPfrWmLydithQ9boBRvsxUVxU58ik7Xm8tTepHofb6vjZMJpx1MvqLvCWWZ1wdmggQxeoNBfHWoTcIMhguJ4Da2DlcZj5Ye9BIcFvHHFTGURb_iGqk28bMXOs7pE8QmOShf7wSgJ0OVuMRyY31jlih0__WG9Q4dmEjE86yUY_8J0qo&amp;data=05%7C02%7Cmsiegel%40axsome.com%7Cb0ad9a0787784e7305e308dda9c74deb%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C638853395639221688%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=Y85uAjK%2B8ysZNvbrHQAmApGPYT7mUKwtYyw%2FV0cvCcE%3D&amp;reserved=0"><strong><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">X</span></span></strong></a><span data-contrast="none">.</span> </p>
<p><strong><span data-contrast="auto">About This Role</span></strong><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p>
<p><span data-contrast="none">Axsome Therapeutics is seeking a Pharmacovigilance Scientist</span><strong> </strong><span data-contrast="none">to </span><span data-contrast="none">establish and execute pharmacovigilance (PV) systems and procedures, with a strong focus on maintaining high-quality standards</span><span data-contrast="none">. This role</span><strong> </strong><span data-contrast="none">is responsible for supporting the Pharmacovigilance (PV) Science function under the guidance of the PV physician and providing oversight of ICSR assessment, signal detection, medical surveillance and risk management activities for investigational products in clinical development and marketed products. This position collaborates with key internal stakeholders, including Clinical Development, Commercial, Medical Information, Medical Affairs, Quality, Regulatory and Legal, as well as multiple external Service Providers and partners on pharmacovigilance-related matters.&nbsp;</span><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p>
<p><span data-contrast="none">This position reports to Executive Director of Pharmacovigilance/Drug Safety and </span><span data-contrast="auto">is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.&nbsp;&nbsp;</span><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p>
<p><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span><strong><span data-contrast="none">Job Responsibilities and Duties</span></strong><span data-contrast="none"> include, but are not limited to, the following:</span> <span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Assist safety physician to enhance safety surveillance and signal detection by monitoring and analyzing safety data from various sources to identify potential safety signals or trends related to investigational and marketed products</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Contribute to the creation and execution of risk minimization measures to mitigate identified risks.</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Support the preparation pharmacovigilance aggregate safety reports (e.g., PADER, PSURs, DSURs) to regulatory authorities to meet compliance requirements.</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="o" data-font="Courier New" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="1" data-aria-level="2"><span data-contrast="auto">Collaborate with PV physician/PV operations and key stakeholders to request/receive applicable sections of the report</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="o" data-font="Courier New" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="2" data-aria-level="2"><span data-contrast="auto">Provide training and guidance to other functions to address ad hoc questions and issues</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="o" data-font="Courier New" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="3" data-aria-level="2"><span data-contrast="auto">Ensure timely finalization of the reports to meet the submission timelines of relevant health authorities and other external stakeholders</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Collaborate and communicate with cross-functional teams to ensure effective safety monitoring and communication</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Support the safety review team (SRT) and coordinates all safety topic discussion and documentation.&nbsp;</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="o" data-font="Courier New" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="1" data-aria-level="2"><span data-contrast="auto">Ensure appropriate stakeholder representation and input at SRT</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="o" data-font="Courier New" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="2" data-aria-level="2"><span data-contrast="auto">Ensure all data is appropriately compiled and presented at SRT for team review</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="o" data-font="Courier New" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:1440,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Courier New&quot;,&quot;469769242&quot;:[9675],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;o&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="3" data-aria-level="2"><span data-contrast="auto">Liaise with SRT chair to facilitate communication and support for decisions resulting from the SRT (e.g. update of RMPs, labeling, regulatory notifications etc.)</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Contribute to clinical trials by providing safety input and reviewing documents such as Clinical Study Reports (CSRs), protocols, and investigator brochures (IB), ICF etc.</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Provide support for the processing of individual case safety reports (ICSRs) and ensure data accuracy and completeness for investigational and marketed products</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">Support the PV SOP updates</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto">Oversee vendor safety process, e.g., signal detection, validation and assessment.&nbsp;</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto">Participate in audit/inspection preparedness activities and provide support during regulatory inspections in collaboration with team members</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="auto">Participate in new study initiation to ensure PV requirements are met including but not limited to safety reporting, query resolution, SAR reconciliation, un-blinding process, and safety reporting training</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="13" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="auto">Evaluate and improve current PV processes, as needed, to strengthen medical surveillance and risk management process ensuring alignment with best practices</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259}">&nbsp;</span></li>
</ul>
<p><strong><span data-contrast="none">Requirements / Qualifications</span></strong> <span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Noto Sans Symbols&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;●&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Master’s degree in health-discipline or equivalent required, RN, R.Ph, or Pharm D degree is highly preferred</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:240}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Noto Sans Symbols&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;●&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">5+ years of progressively responsible Pharmacovigilance experience in a pharmaceutical, biotechnology, or related environment with focused experience in signal detection, safety surveillance, risk mitigation and risk management</span><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Noto Sans Symbols&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;●&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Extensive experience in case processing, regulatory requirements of ICSRs, MedDRA, WHODD, project management&nbsp;</span><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Noto Sans Symbols&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;●&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Experience in submission activities in both FDA and EU is preferred, but not required</span><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Noto Sans Symbols&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;●&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Must demonstrate the ability to draft reports, business correspondence, and procedures, and to effectively present information and respond to questions from internal and external stakeholders, both domestic and international</span><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="●" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Noto Sans Symbols&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;●&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">Ability to work on site Monday, Tuesday &amp; Thursday. We are unable to consider candidates who are looking for fully remote roles.</span><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></li>
</ul>
<p data-ccp-border-bottom="0px none #000000" data-ccp-padding-bottom="0px" data-ccp-border-between="0px none #000000" data-ccp-padding-between="0px"><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259,&quot;335572071&quot;:0,&quot;335572072&quot;:0,&quot;335572073&quot;:4278190080,&quot;335572075&quot;:0,&quot;335572076&quot;:0,&quot;335572077&quot;:4278190080,&quot;335572079&quot;:0,&quot;335572080&quot;:0,&quot;335572081&quot;:4278190080,&quot;335572083&quot;:0,&quot;335572084&quot;:0,&quot;335572085&quot;:4278190080,&quot;335572087&quot;:0,&quot;335572088&quot;:0,&quot;335572089&quot;:4278190080,&quot;469789798&quot;:&quot;nil&quot;,&quot;469789802&quot;:&quot;nil&quot;,&quot;469789806&quot;:&quot;nil&quot;,&quot;469789810&quot;:&quot;nil&quot;,&quot;469789814&quot;:&quot;nil&quot;}">&nbsp;</span><strong><span data-contrast="none">Experience and Knowledge</span></strong><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:160,&quot;335559740&quot;:259,&quot;335572071&quot;:0,&quot;335572072&quot;:0,&quot;335572073&quot;:4278190080,&quot;335572075&quot;:0,&quot;335572076&quot;:0,&quot;335572077&quot;:4278190080,&quot;335572079&quot;:0,&quot;335572080&quot;:0,&quot;335572081&quot;:4278190080,&quot;335572083&quot;:0,&quot;335572084&quot;:0,&quot;335572085&quot;:4278190080,&quot;335572087&quot;:0,&quot;335572088&quot;:0,&quot;335572089&quot;:4278190080,&quot;469789798&quot;:&quot;nil&quot;,&quot;469789802&quot;:&quot;nil&quot;,&quot;469789806&quot;:&quot;nil&quot;,&quot;469789810&quot;:&quot;nil&quot;,&quot;469789814&quot;:&quot;nil&quot;}">&nbsp;</span></p>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Knowledge of ICH E2B(R2) and (R3) specifications and entry guidance.</span><span data-ccp-props="{&quot;134233279&quot;:true,&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">Knowledge of global pharmacovigilance reporting rules and timelines, including but not limited to Health Canada, FDA and EMA.</span><span data-ccp-props="{&quot;134233279&quot;:true,&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Knowledge of relevant food and drug administration (FDA), European union (EU) and international conference on Harmonization (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.&nbsp;</span><span data-ccp-props="{&quot;134233279&quot;:true,&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Ability to interpret health and medical records such as adverse event reporting forms, a discharge summary, etc.</span><span data-ccp-props="{&quot;134233279&quot;:true,&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Experience with clinical and/or post-marketing case assessment, including medical terminologies, MedDRA and WHO DD coding and narrative writing.</span><span data-ccp-props="{&quot;134233279&quot;:true,&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">Experience with safety database is required; ARISg is a plus but not mandatory.</span><span data-ccp-props="{&quot;134233279&quot;:true,&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">Experience with Veeva is a plus but not mandatory.</span><span data-ccp-props="{&quot;134233279&quot;:true,&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="none">Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members&nbsp;</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559739&quot;:0,&quot;335559740&quot;:240}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto">Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines&nbsp;</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto">Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations&nbsp;</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="auto">Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="auto">Excellent verbal and written communication and skills</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}">&nbsp;</span></li>
</ul>
<ul>
<li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="none">Excellent in detailed-oriented tasks.</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}">&nbsp;</span></li>
</ul>
<p><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335551550&quot;:6,&quot;335551620&quot;:6,&quot;335559685&quot;:720,&quot;335559739&quot;:0,&quot;335559740&quot;:240}">&nbsp;</span><strong><span data-contrast="none">Salary &amp; Benefits&nbsp;</span></strong><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p>
<p><span data-contrast="none">The anticipated salary range for this role is $150,000 – $185,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.</span><span data-ccp-props="{&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p>
<p><em><span data-contrast="auto">Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.</span></em><span data-contrast="auto"> </span><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p>
<p><em><span data-contrast="auto">Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.</span></em><span data-ccp-props="{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;335551550&quot;:6,&quot;335551620&quot;:6}">&nbsp;</span></p>
Axsome Therapeutics
BIOTECHNOLOGY
CNS treatments
LocationNY - New York
Open Jobs182
Neurology
View Company ProfilePipeline
SunosiN/A
Solriamfetol 150 mg Oral TabletPhase 1
SolriamfetolPhase 2
AXS-12Phase 2
AXS-05Phase 2