Associate Director, Senior Patient Safety Scientist
Core
Leads the review of safety data and documents for potential safety issues, authors PV input to safety documents and regulatory reports, and presents safety data and analyses.
Role type
Senior IC patient safety scientist (pharmacovigilance)
Builds
Global Risk Management Plans, Risk Evaluation and Mitigation Strategies (REMS), Investigator Brochures, Protocols, Clinical Study Reports, Reference Safety Information, periodic regulatory documents (PBRERs, PSURs, DSURs), and regulatory submissions (NDA/BLA, MAA).
Domain
Pharmaceutical/Biotechnology/CRO - Pharmacovigilance and Drug Development
Required skills
Pharmacovigilance (PV) regulations, Safety strategy and management, Signal management, Periodic safety reports, Safety sections of protocols/IBs/ICFs/CSRs, Regulatory responses, Clinical development safety, Risk management planning, Contract negotiation for PS components, Training and mentoring.
Preferred skills
Epidemiology, MD/MSc/PhD in scientific discipline.
Technologies
ICH guidelines, US/EU/UK pharmacovigilance regulations.
Responsibilities
Lead proactive PV and risk management planning for complex products; Lead PS activities for cross-functional project teams; Provide safety expertise to clinical study documents; Present complex issues to Safety Information Review Committee (SIRC); Author Reference Safety Information (RSI) for complex development products; Author/oversight for periodic regulatory documents; Provide strategic leadership for regulatory submissions; Participate in contract negotiations for PS components; Train and mentor junior team members.
Seniority
Senior, hands-on IC with leadership responsibilities