Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist)
Core
Lead proactive signal detection, benefit-risk analyses, and safety monitoring/reporting for clinical and marketed products across the full product lifecycle.
Role type
Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist)
Builds
Aggregate safety reports (IND/NDA Annual Reports, PADER, DSUR, PSUR, PBRER), safety signal assessment reports, and risk management strategies.
Domain
Biopharmaceuticals / Neuroscience / Drug Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Proactive signal detection, benefit-risk analysis, safety monitoring and reporting, authoring aggregate safety reports, reviewing safety concerns and escalated issues, maintaining safety profiles, analyzing serious events of interest, preparing safety data for governance, developing risk management strategies, reviewing clinical study documents (protocols, ICF, CSR), writing SOPs, audit preparedness
Preferred skills
Master's degree, management experience in pharma/biotech
Technologies
Global drug safety regulations and guidelines (ICH, FDA, EMA)
Responsibilities
Lead proactive signal detection and benefit-risk analyses; Author and manage Aggregate Safety Reports; Review safety concerns and support development of safety responses; Maintain continuous monitoring of safety profiles; Participate in cross-functional Safety Risk Management Team (SRMT) meetings; Review and provide input to clinical study documents; Write and maintain Standard Operating Procedures (SOPs); Support regulatory inspections
Seniority
Director/Senior Director, Management
