SERM Medical Director / SERM Scientific Director
Core
Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets for complex Classic & Established Products with ongoing litigation.
Role type
Senior IC Medical/Scientific Director (Pharmacovigilance)
Builds
Safety strategies, regulatory submissions, and risk-reduction plans for established pharmaceutical products.
Domain
Pharmaceuticals / Drug Safety / Pharmacovigilance
Required skills
Pharmacovigilance, Safety evaluation, Risk management, Clinical data synthesis, Regulatory knowledge, Cross-functional leadership, Inspection readiness, Benefit-risk assessment, Strategic communication, Legal interaction
Preferred skills
Board certification, Specialist registration, PhD/PharmD, Advanced postgraduate qualification
Technologies
ICH guidance, Good Pharmacovigilance Practices, CIOMS guidance
Responsibilities
Lead Pharmacovigilance and Risk Management Planning; Lead safety component of global regulatory submissions; Lead safety governance and Safety Review Teams; Represent GSK in discussions with health authorities and legal depositions; Escalate safety issues to senior management and governance committees.
Seniority
Senior, hands-on IC with leadership responsibilities