• Conduct triage for incoming cases, evaluating seriousness, expectedness, and relatedness, in collaboration with safety physicians and medical directors.
• Author high-quality case narratives and contribute to the analysis of similar events for the medical review of ICSRs, extracting relevant information from source documents.
• Assist in the production of accurate safety reports (ICSRs, CIOMS/MedWatch Forms) for submission to regulatory authorities.
• Monitor day zero and due dates for regulatory submissions in collaboration with regulatory documents.
• Generate medical safety queries as needed for clarification of clinical reports.
• Perform active case medical follow-up, including written and verbal communication with clinical investigators and sites.
• Support the management of case processing deadlines in collaboration with the PV operations lead.
• Conduct and facilitate safety data review meetings periodically and ad-hoc; manage safety profile review, safety surveillance, and signal management in the context of aggregate data review.
• Lead the Safety Management team in collaboration with other PV personnel (e.g., safety operations lead).
• Review and communicate trending, signaling, and other safety-related issues promptly.
• Contribute to the Safety Governance process by preparing and presenting safety data; assess safety data for ongoing periodic/aggregate safety data reviews, providing recommendations for review and approval by the Safety Review Committee.
• Review final drafts of the IND annual safety reports and DSURs in collaboration with other stakeholders.
• Compile safety information for aggregate safety reports in support of meetings and reviews.
• Contribute to safety sections of various documents, including clinical study protocols, ICF, IB, INDs, DSURs, and CSRs.
• Lead and facilitate Safety management meetings; author relevant sections of the SMP; configure and run safety line listings/reports in the global safety database.
• Provide vendor management and oversight for relevant areas.
• Oversee MedDRA and WHO Drug coding.
• Author SOPs and WIs relevant to the role.
• Review the RMP strategy in collaboration with stakeholders, serving as the main author for the scientific and medical sections of the RMP.
• Review safety concerns escalated from internal and external stakeholders and develop strategies for safety assessment.
• Collaborate across cross-functional areas to facilitate reviews of safety data.
• Perform other duties as assigned.
• Medical (MD), nursing (RN), or pharmacy (PharmD) degree required.
• 7 years of experience in drug safety and pharmacovigilance in the pharmaceutical industry.
• Strong understanding of local and applicable global safety regulations, medical terminology, and drug development processes.
• Clinical background with the ability to interpret medical records.
• Experience with safety databases, audits, and regulatory inspections.
• Excellent verbal and written communication skills, including presentation skills.
• Strong time management and multitasking abilities, with a focus on high-quality work in a dynamic environment.