Global Safety Program Lead
Core
Lead global safety strategy, delivery, and oversight for assigned pharmaceutical assets, managing safety physicians and scientists to optimize benefit-risk profiles and ensure regulatory compliance.
Role type
Senior IC Global Safety Program Lead
Builds
Safety strategies, Risk Management Plans (RMPs), Periodic Safety Reports (PSRs), and regulatory submissions for infectious disease therapeutics.
Domain
Pharmaceutical / Biotechnology / Clinical Safety / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic safety planning, team leadership (physicians/scientists), regulatory submission management, pharmacovigilance standards, cross-functional influence, data interpretation, risk mitigation, global stakeholder engagement
Preferred skills
PhD in scientific discipline, conference speaking experience, deep expertise in specific disease areas
Technologies
GxP practice, Safety Health and Environment (SHE) standards, regulatory agency systems
Responsibilities
Accountable for overall scientific and clinical safety content; lead safety physicians and scientists; ensure compliance with PV regulations; deliver analyses of clinical safety data; represent the company at global governance forums; manage safety communication and messaging; lead response to complex technical safety issues
Seniority
Senior, hands-on IC with line management responsibilities
