PRA Health SciencesSr Director Drug Safety and PV
Nov. 2016 - Dec. 2018San Diego CA • Revamp pharmacovigilance signal detection aspects and SOPs.
• Directed launch readiness for assigned clients including regulatory filings and safety strategies.
• Established safety governance and inspection-ready infrastructure.
• Write, edit, and governance of Safety documents (PSMF, RMP, DSUR, PSUR, IND/NDA annual reports, IB, ICSF, DIL)
• PSMF oversight of assigned products