DIRECTOR / ASSOCIATE DIRECTOR, SAFETY EVALUATION AND RISK MANAGEMENT (SERM)

137975
  • Competitive
  • -, United States
  • Permanent

MEDICAL REVIEW:

• 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.

SAFETY EVALUATION:

• 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.

RISK MANAGEMENT:

• 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.

QUALIFICATIONS:

• 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.

Shannon Mattiolo Senior Recruiter

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