Associate Medical Director, Safety Evaluation and Risk Management (SERM)
Core
Provide medical/scientific expertise in safety evaluation and risk management for GSK assets in clinical development and post-marketing settings.
Role type
Associate Medical Director, Safety Evaluation and Risk Management (SERM)
Builds
Clinical safety and pharmacovigilance strategy for assets within Global Safety
Domain
Pharmaceutical industry, drug safety, pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Signal detection and evaluation, regulatory periodic reports authoring, risk management, causality assessment, benefit-risk assessment, international pharmacovigilance requirements knowledge, clinical trial design, scientific communication, cross-functional matrix leadership, process improvement, SOP development
Preferred skills
Safety governance committee leadership, global regulatory filings experience (IND/CTA, NDA/BLA, EMA/MHRA MAAs), external pharmacovigilance initiative contribution, complex safety situation decision-making, matrix organization leadership
Technologies
ICH guidelines, GVP modules, CIOMS initiatives
Responsibilities
Drive production of regulatory periodic reports and RMPs globally; author SERM safety contribution to global regulatory submissions; present complex issues to senior governance committees; support and facilitate safety governance/SRTs; lead or participate in cross-functional process initiatives; coach and mentor others
Seniority
Senior, hands-on IC with strategic influence
