Global Safety Program Lead
Core
Lead the global safety strategy, delivery, and oversight for assigned pharmaceutical assets and indications, managing a team of safety physicians and scientists to optimize benefit-risk profiles.
Role type
Senior Director, Global Safety Program Lead
Builds
Global safety strategies, Risk Management Plans (RMPs), Periodic Safety Reports (PSRs), and regulatory submissions for clinical programs.
Domain
Pharmaceutical / Biotechnology / Clinical Safety / Pharmacovigilance
Required skills
Strategic safety planning, team leadership (physicians/scientists), pharmacovigilance expertise, regulatory submission management, risk mitigation, cross-functional collaboration, data interpretation, global regulatory agency interaction.
Preferred skills
PhD in scientific discipline, industry conference speaking experience, deep clinical safety expertise in specific disease areas.
Technologies
GxP, Safety & Strategy Management Team (SSaMT), Safety Surveillance Team, DRC, eCRC, SARB, FSIRB, DSMB/DMC, MARC, CPT, GPT.
Responsibilities
Accountable for overall scientific and clinical safety content; implement safety teams; lead response to complex technical safety issues; ensure compliance with PV regulations; represent the company at governance forums; manage safety physicians and scientists; deliver analyses of clinical safety data.
Seniority
Senior Director, Line Management