5 years clinical safety and risk management experience
Global regulatory submission experience
The Global Safety Program Lead is accountable for the overall safety strategy, delivery, and oversight of assigned assets while managing a team of safety physicians and scientists
Job Summary
The Global Safety Program Lead is accountable for the overall safety strategy, delivery, and oversight of assigned assets while managing a team of safety physicians and scientists.
This role requires thorough knowledge of global pharmacovigilance standards, including pre and post-launch experience, to ensure compliance with GxP practices and local regulations.
The successful candidate will provide strategic safety knowledge to product teams, lead responses to complex technical issues, and represent the company at major governance forums.
Matching Summary
The Global Safety Program Lead is accountable for the overall safety strategy, delivery, and oversight of assigned assets while managing a team of safety physicians and scientists.
Skills & Requirements
Must-have
Medical degree or equivalent in biomedicine
5 years clinical safety and risk management experience
Global regulatory submission experience
Leadership of safety physicians and scientists
Knowledge of pharmacovigilance standards
Nice-to-have
PhD in scientific discipline
Industry conference speaking experience
Experience with in-licensing opportunities
Strong cross-functional collaboration skills
Independent judgment on complex safety issues
Key Requirements
Medical degree or equivalent
5+ years pharmaceutical safety experience
Proven track record in clinical safety delivery
Experience leading medical directors/scientists
Ability to travel domestically and internationally