Associate Director, Senior Patient Safety Scientist
Core
Leads the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and (Associate) PV Scientist, authors and leads 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, Informed Consents, Clinical Study Reports, Reference Safety Information (RSI), periodic regulatory documents (PBRERs, PSURs, DSURs), and regulatory submissions (NDA/BLA, MAA).
Domain
Pharmaceutical/Biotechnology/Regulatory
Required skills
Pharmacovigilance (PV) regulations, Risk management planning, Signal management, Periodic safety reports, Clinical development safety, Regulatory submissions, Contract negotiations, Team leadership, Mentoring
Preferred skills
Epidemiology, MD/MSc/PhD in scientific discipline
Technologies
None stated
Responsibilities
Leads proactive pharmacovigilance and risk management planning for complex products; Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products; Provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports; Acts as Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects; Presents complex issues to Safety Information Review Committee (SIRC) and leads data evaluation; Collaborates with GSP and Clinical representatives to author Reference Safety Information (RSI); Authors/provides strategic input for periodic regulatory documents (PBRERs, PSURs, DSURs); Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications; Participates in negotiations and provides expertise to the PS component of contracts/agreements with third parties; Trains and mentors junior members of the team.
Seniority
Senior, hands-on IC