Global Safety Program Lead
Core
Lead the global safety strategy, delivery, and oversight for assigned pharmaceutical assets, managing a team of safety physicians and scientists to optimize benefit-risk profiles and ensure regulatory compliance.
Role type
Senior line manager, clinical safety program lead
Builds
Safety strategies, Risk Management Plans (RMPs), Periodic Safety Reports (PSRs), and regulatory submissions for specific drug assets
Domain
Pharmaceutical industry, clinical pharmacovigilance and safety
Required skills
Strategic safety planning, team leadership, regulatory compliance (GxP), risk mitigation, data interpretation, cross-functional collaboration
Preferred skills
Experience with in-licensing opportunities, knowledge of emerging clinical safety developments, global network building
Technologies
GxP practice, Safety & Strategy Management Team (SSaMT), Safety Surveillance Team
Responsibilities
Accountable for overall scientific and clinical safety content for assigned assets; Line manages a team of safety physicians and/or scientists; Leads response to complex technical safety issues; Ensures compliance with Safety Health and Environment (SHE) standards; Represents the company at global patient safety governance forums.
Seniority
Senior, hands-on IC with line management responsibilities