Senior Patient Safety Specialist

<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we&#39;re committed to making a difference.</p><p></p><p></p><p><b><u>Key Accountabilities</u></b><u>:</u><br /> </p><p><b>General</b></p><ul><li>Maintain expert-level knowledge of safety profiles, labeling, and global regulations</li><li>Lead development of project-specific procedures and workflows</li><li>Provide technical guidance to junior team members</li><li>Prepare for and participate in audits and inspections</li><li>Analyze metrics and drive continuous improvement</li><li>Collaborate with cross-functional teams on safety deliverables</li><li>Identify risks and recommend mitigation strategies</li><li>Ensure compliant documentation and archiving</li></ul><p></p><p><b>ICSR Processing </b></p><ul><li>Lead project management including safety procedure development and database setup</li><li>Coordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)</li><li>Manage case documentation including narratives, reconciliation, and quality control</li><li>Generate safety reports, listings, and respond to ad hoc requests</li><li>Support quality assurance activities, audits, and file maintenance</li><li>Collaborate with Medical Directors and represent team in client/investigator meetings</li><li>Delegate tasks appropriately and escalate scope changes to management</li><li>Assist with resource planning and cross-functional coordination</li><li>Generate, report, and reconcile compliance metrics in coordination with internal and external stakeholders, as applicable</li></ul><p></p><p><b>Safety Submissions</b></p><ul><li>Execute ICSR and periodic report submissions to authorities with expert-level proficiency</li><li>Manage portal/gateway setup and product registration processes</li><li>Coordinate unblinding procedures and aggregate report schedules</li><li>Quality control case reports and listings</li><li>Develop and refine global safety reporting procedures and systems</li><li>Analyze compliance metrics and lead quality improvement initiatives</li><li>Serve as SME in regulatory reporting requirements and represent team in audits</li><li>Mentor junior staff and contribute to strategic project management</li><li>Lead client meetings and support cross-functional coordination for timely submissions</li></ul><p></p><p><b>Literature (Search and Review)</b></p><ul><li>Develop and maintain comprehensive literature search strategies aligned with client parameters</li><li>Process citations, review records, and maintain local journal monitoring</li><li>Perform quality checks on search methodologies and implement thesauri updates</li><li>Screen publications for adverse drug reactions and potential safety signals</li><li>Flag relevant findings for medical review and signal detection</li><li>Resolve literature search issues through stakeholder collaboration</li><li>Stay current with literature review guidelines and support training initiatives</li><li>Monitor literature review activities to be aligned with global pharmacovigilance regulations (e.g., EMA, FDA, ICH) and client-specific requirements.</li></ul><p></p><p><b>Affiliate Services</b></p><ul><li>Serve as primary liaison between global safety operations and local affiliates</li><li>Maintain product information and reporting rules in client systems</li><li>Coordinate safety information exchange between headquarters and country offices</li><li>Ensure local compliance with country-specific pharmacovigilance requirements; Support compliance activities including late case investigations</li><li>Support local health authority interactions and information requests</li><li>Manage translation requirements for safety documents across regions</li><li>Coordinate local literature monitoring programs with affiliate teams</li><li>Support implementation of global safety processes at local level</li><li>Provide training to affiliate staff on pharmacovigilance procedures</li><li>Manage follow-ups and query resolution</li><li>Perform periodic data reconciliation and manage safety communications</li><li>Participate in regular client meetings</li></ul><p></p><p><b>Regulatory Intelligence</b></p><ul><li>Research and maintain drug/device safety reporting regulatory intelligence</li><li>Conduct country requirement reviews and support QC activities</li><li>Liaise with authorities to obtain regulatory updates</li><li>Maintain databases and respond to safety reporting queries</li><li>Support GPIO team operations and client interactions</li><li>Ensure compliance with SLAs and KPIs for internal/external clients</li><li>Provide functional expertise to PV Operations staff</li><li>Support audits and process improvement initiatives</li><li>Serve as SME for stakeholders and mentor new team members</li><li>Stay current with relevant regulations and procedures</li><li>Disseminate timely and actionable intelligence to internal teams and clients through summaries, alerts, and presentations.</li><li>Work closely with cross-functional teams including Regulatory Affairs, Quality Assurance, and Safety Operations to ensure alignment and integration of regulatory changes.</li><li>Maintain a centralized repository of regulatory intelligence and contribute to the development of SOPs, training materials, and best practices.</li></ul><p></p><p><b>Regulatory Support</b></p><ul><li>Manage regulatory applications, submissions, and product lifecycle changes in Safety databases</li><li>Assess regulatory impact for variations and create marketing packages</li><li>Support global regulatory activities across multiple regions (EU, US, Asia, Middle East, Africa)</li><li>Perform data remediation for product portfolios during mergers/acquisitions</li><li>Prepare submission packages and track regulatory documents (RMP, PBRER, HASR, PASS)</li><li>Validate data against SmPC and manage xEVMPD submissions</li><li>Create quality control reports and provide technology support</li><li>Maintain accurate records and perform reconciliation activities</li></ul><p></p><p><b><u>Skills:</u></b></p><ul><li>Expert knowledge of drug safety regulations and pharmacovigilance processes</li><li>Strong analytical and problem-solving abilities</li><li>Excellent communication and presentation skills</li><li>Superior organizational and time management capabilities</li><li>Proficiency with pharmacovigilance systems and databases</li></ul><p></p><p><b><u>Knowledge and Experience</u></b>:</p><ul><li>Proven experience in safety case management and regulatory reporting</li><li>Proficiency with safety databases and data analysis</li><li>Strong knowledge of ICH guidelines and regional requirements</li><li>Demonstrated mentoring abilities and process improvement skills</li><li>Experience in pharmaceutical or healthcare environments</li></ul><p></p><p><b><u>Education:</u></b></p><ul><li>Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience</li></ul>