Associate Director, Pharmacovigilance

<p style="text-align:left"><u><b>Job Description:</b></u></p><p style="text-align:inherit"></p><p>The Associate Director of Pharmacovigilance (PV) supports the daily management and execution of pharmacovigilance operations, ensuring compliance with regulatory requirements, PV agreements, and internal SOPs. This role supports medical review and review of medical coding, vendor management, SOP development, safety responsibilities for the clinical operations, document reviews etc.</p><p>This role contributes to the oversight of drug safety activities, supports cross-functional safety initiatives, and helps maintain inspection readiness across the PV function</p><p>This position reports to the VP of Pharmacovigilance.</p><p><u>Key Responsibilities:</u></p><p><u>Leadership and Operational Support:</u></p><p>- Support development and execution of PV strategy, goals, and departmental objectives.</p><p>- Coordinate with external vendors and partners to support PV activities and ensure adherence to management plans and contracts.</p><p>- Provide guidance to PV team members, including case managers and safety scientists, helping ensure high‑quality work output.</p><p>- Assist in developing, implementing, and maintaining PV processes, SOPs, and quality standards in alignment with global regulations (ICH, FDA, EMA).</p><p><u>Safety Data Management:</u></p><p>- Support oversight of adverse event (AE) collection, review, and reporting from clinical trials and post‑marketing surveillance.</p><p>- Participate in the medical review process for ICSRs, as appropriate.</p><p>- Contribute to signal detection activities and support investigations into potential safety concerns.</p><p>- Coordinate cross‑functional and vendor-supported preparation of periodic safety reports (PSURs, DSURs).</p><p>- Assist in analysis of safety data to support benefit‑risk assessments, signal evaluations, REMS activities, and periodic reporting.</p><p>- Support identification and management of safety database vendors.</p><p><u>Risk Management:</u></p><p>- Assist in development and maintenance of Risk Management Plans (RMPs).</p><p>- Support risk assessments and implementation of mitigation strategies.</p><p>- Collaborate with clinical development, medical affairs, and regulatory teams to ensure safety considerations are incorporated into development and commercialization plans.</p><p>- Support QA with medical and safety‑related assessments for product complaints.</p><p>- Contribute to SOP development and updates.</p><p></p><p><u>Regulatory Compliance:</u></p><p>- Support PV readiness for regulatory inspections, ensuring documentation and processes are maintained.</p><p>- Assist in responding to regulatory inquiries and preparing required safety documentation.</p><p>- Stay informed on evolving global PV regulations and best practices.</p><p></p><p><u>Cross</u><u>‑</u><u>Functional Collaboration:</u></p><p>- Collaborate with clinical operations, medical affairs, quality assurance, and other internal stakeholders.</p><p>- Represent the PV function on internal teams as needed.</p><p></p><p><u>Required Skills and Experience:</u></p><p>- Advanced degree in medicine, pharmacy, nursing, or related scientific field preferred.</p><p>- Minimum of 6–8 years of experience in drug safety operations (case management, signal detection, risk management, regulatory reporting).</p><p>- Experience working with external vendors/CROs required.</p><p>- Experience in cardiovascular disease and post‑marketing PV activities preferred.</p><p>- Strong communication, collaboration, and organizational skills.</p><p>- Proficiency with safety database systems and PV software tools.</p><p></p><p></p><p><u><b><span>Salary and Benefits:</span></b></u><br /><br /><span>We offer a competitive base salary, annual bonus, and long-term incentives. In addition, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, and retirement plans.</span><br /><br /><span>NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.</span></p>