Apply for ED/VP, Global Drug Safety Lead via BioTalent

Vice President - Global Safety Drug Lead

BioTalent is Headhunting for a US based VP - level Global Safety Drug Lead. This upper senior manager role is integral to shaping the global safety strategy and maintaining the safety profile for our products throughout their lifecycle. Collaborate with Clinical Development, Regulatory Affairs, and other key departments to promote a robust drug safety culture.

Offer:

Permanent position
Attractive salary, >30% bonus, 401k, Medical plan
Hybrid (Offices East and West Coast US) or Remote within the US with business travel.

Develop and implement risk management strategies for innovative assigned products.
Lead and author key pharmacovigilance documents, including medical safety assessments and regulatory responses, applying regulatory guidance for safety surveillance and document authorship.
Oversee timely submission of safety reports to global regulatory authorities, including PBRERs/PSURs, DSURs, and safety components of IND/NDA/MAA filings.
Collaborate with cross-functional teams for safety assessments, ongoing surveillance, and related communication.
Analyze and communicate aggregate safety data to cross-functional teams and senior management.
Build strong relationships with KOLs, external experts, and industry associations, staying updated on industry trends and participating in global collaborative projects.
Design and deliver drug safety training programs.

Requirements:

MD in a clinical or scientific field (or equivalent education, training, and experience).
Minimum 10 years’ experience in drug safety/pharmacovigilance within clinical development.
Experience in the pharmaceutical or biotech industry, particularly with Phase I-III clinical trials.
Therapy area alignment to Oncology would be advantageous.
Familiarity with global PV regulatory environments (regulations FDA/EMA, initiatives, standards, GVP).
Proven ability to lead cross-functional teams.
Excellent interpersonal and ownership skills.