About The Position
The Medical Evaluation Manager works in the Case Management team within Global Safety and Pharmacovigilance (GSPV). The role oversees vendor delivery of timely, high-quality medical evaluations, trains vendor Medical Evaluators, guides complex cases, and establishes assessment frameworks to support the quality of Individual Case Safety Reports (ICSRs). The position also contributes to global medical evaluation strategy, addresses challenges, and drives process improvements through cross-functional collaboration.
Requirements
- Advanced Medical or Pharmacy degree (e.g., MD or PharmD), or international equivalent.
- Seven years of pharmaceutical or CRO industry experience, a significant proportion of which should be in a medical evaluation role.
- Broad overview of all aspects of a pharmacovigilance system and specific experience with regulatory requirements.
- Deep knowledge of pharmacovigilance concepts, including CIOMS, listedness/expectedness, causality assessment, common adverse-event grading and coding conventions, and ICSR management.
- Experience and success in addressing and managing complex medical issues in pre-approval and post-approval environments.
- Ability to convey complex concepts through clear and concise messages.
- Ability to demonstrate two-way communication by seeking and incorporating feedback to improve output and alignment.
- Ability to provide appropriate direction, gain commitment, develop, and empower others.
Nice To Haves
- Experience in the medical assessment of complex biologic products, including vaccines and combination products.
Responsibilities
- Oversee vendor activities to ensure high-quality, timely medical evaluation and processing of individual case safety reports.
- Apply medical and scientific judgment to assess safety information, including causality, expectedness, seriousness, and clinical relevance.
- Ensure medical evaluation activities comply with pharmacovigilance regulations, company standards, and applicable SOPs.
- Contribute to continuous process improvement, including reviewing and enhancing safety-relevant procedures.
- Collaborate with internal GSPV functions, cross-functional stakeholders, and the vendor to ensure consistent, high-quality safety assessments.
- Deliver onboarding training or knowledge-sharing activities to vendor Medical Evaluators.
- Identify potential challenges, risks, and roadblocks associated with the global medical evaluation strategy and work cross-functionally to develop solutions.
- Support monitoring of vendor performance, training, workload, and issue resolution through appropriate governance and oversight.
- Respond clearly and promptly to health authority queries related to case medical evaluation.
- Identify resources and tools needed to facilitate risks and implement necessary risk management initiatives.
- Interface with high-level internal and external stakeholders and contribute to and approve regulatory reports, submissions, and responses to queries.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
