Associate Director, Patient Safety Scientist
Core
Leads proactive pharmacovigilance and risk management planning, evaluates clinical implications of safety data to establish drug safety profiles, and authors strategic input for regulatory documents.
Role type
Senior IC patient safety scientist (pharmacovigilance)
Builds
Global Risk Management Plans, Reference Safety Information, periodic regulatory reports (PBRERs, PSURs, DSURs), and regulatory submissions (NDA/BLA, MAA)
Domain
Life sciences / Pharmacovigilance / Regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Patient safety expertise, clinical/drug development experience, pharmacovigilance regulations knowledge, safety data evaluation, regulatory document authoring, cross-functional collaboration, meeting leadership, training
Preferred skills
MD/MSc/PhD in scientific discipline, epidemiology data understanding
Technologies
PV tools and systems
Responsibilities
Lead proactive pharmacovigilance and risk management planning for designated products; Represent PS on cross-functional project teams for developmental and marketed products; Present safety information at external meetings; Lead Safety Strategy and Management Team (SSaMT) for smaller projects; Present issues to Safety Information Review Committee (SIRC) and lead data evaluation discussions; Produce evaluation documents for internal or regulatory authority requests; Collaborate with GSP and Clinical representatives to author Reference Safety Information (RSI); Evaluate clinical implications of safety data from pre-clinical, clinical, and literature sources; Author strategic input for periodic regulatory documents and new product submissions; Contribute to PS components of third-party contracts; Train junior team members in PS tools and systems
