GSK
Associate Medical Director, Safety Evaluation and Risk Management (SERM)
$87K–$145K
Durham 300 Morris Street +3 · Hybrid (Remote & On-site) · Director · Full-time · Posted Sep 24, 2026
- Location
- Durham 300 Morris Street
Greater Poland
UK – London – New Oxford Street
Belgium-Wavre - Experience
- No number of years specified.
- Education
- Medical degree with completion of formal postgraduate clinical training, residency, or specialty training.
About the job
Provides medical and scientific leadership for safety evaluation and risk management of GSK products in clinical development and/or post-marketing, guiding pharmacovigilance strategy and evidence-based safety decisions.
What you'll do
- Detects and evaluates safety signals; prepares periodic regulatory reports, risk management plans, and safety contributions to global submissions.
- Supports safety governance and cross-functional teams, recommending safety-risk characterization and mitigation in study protocols or product labeling.
- Presents safety assessments to senior governance groups and contributes to process improvement, regulatory compliance, and scientific communications.
What they ask for
- Medical degree and completion of formal postgraduate clinical, residency, or specialty training.
- Pharmaceutical or biotechnology industry experience in pharmacovigilance or drug safety.
- Experience in clinical safety and pharmacovigilance, including evidence generation, benefit–risk and causality assessments, and safety-signal evaluation.
- Experience with international pharmacovigilance requirements and drug development and approval processes, such as ICH, GVP modules, or CIOMS initiatives.
Nice to have
- Experience with successful global regulatory filings (e.g., IND/CTA, NDA/BLA, and EMA/MHRA MAAs).
- Experience in safety governance, matrix leadership, or external pharmacovigilance initiatives.
Pay
PLN 0 to PLN 0 (base salary; annual gross) ; EUR 87,000 to EUR 145,000 (base salary; annual gross)
Tools
ICH, GVP modules, CIOMS, IND/CTA, NDA/BLA, EMA/MHRA MAAs, Good Clinical Practice (GCP)
Model-written summary · the original posting is authoritative