Global Safety Program Lead/Sr Medical Director
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.
Role type
Senior Director, Global Safety Program Lead (Medical Director)
Builds
Safety strategies, Risk Management Plans (RMPs), Periodic Safety Reports (PSRs), and regulatory submissions for clinical programs.
Domain
Pharmaceutical industry, Clinical Safety, Pharmacovigilance
Required skills
Medical degree or equivalent in biomedicine/science, Clinical safety strategy, Pharmacovigilance standards, Global regulatory submissions, Team leadership, Cross-functional influence, Data interpretation, Risk mitigation
Preferred skills
PhD in scientific discipline, Conference speaking experience, Disease area expertise
Technologies
GxP, PV regulations, Clinical trial systems
Responsibilities
Accountable for overall scientific and clinical safety content for assigned assets, Lead response to complex technical safety issues, Ensure compliance with global and local regulations, Manage safety physicians and scientists, Represent company at governance forums (DRC, SARB, DSMB), Drive safety contribution to study designs.
Seniority
Senior Director, Line Management