Global Safety Program Lead
Core
Lead 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 IC safety program lead (pharmaceuticals)
Builds
Safety strategies, Risk Management Plans (RMPs), Periodic Safety Reports (PSRs), and regulatory submissions for clinical programs
Domain
Pharmaceuticals / Clinical Safety / Pharmacovigilance
Required skills
Medical degree or equivalent in biomedicine/science, strategic safety planning, team leadership (physicians/scientists), global regulatory submissions, pharmacovigilance standards, cross-functional influence, data analysis and interpretation, risk mitigation
Preferred skills
Experience in in-licensing opportunities, presenting to senior governance bodies, managing complex technical safety issues
Technologies
GxP, PV regulations, clinical trial systems
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 and global/local regulations; Represents the company in global patient safety governance forums; Delivers analyses of clinical safety data to inform labeling globally.
Seniority
Senior, hands-on IC with line management responsibilities