VP, Global Drug Safety & PV Leader — Biotech

Cornerstone Search Group; New York (NY); Híbrido; USD 250.000 - 350.000; Jornada completa

Descripción de la vacante

Cornerstone Search Group, on behalf of a clinical-stage biotechnology company, seeks a Global Head of Drug Safety & PV to lead safety strategy and build the DS & PV function in the Boston/Cambridge area with hybrid work. This senior role reports to the Chief Medical Officer and sits on the leadership team.

You will shape global safety standards, drive regulatory submissions, establish scalable safety infrastructure, manage external resources, and mentor a high-performing team across programs.

Formación

• MD with 12+ years of experience in drug safety, pharmacovigilance, and risk management in the biopharma industry.
• Prior experience as Head of DS & PV, including building and leading safety teams across operational, compliance, and medical functions.
• Late-stage clinical development experience and direct involvement in BLA/NDA and/or MAA submissions.
• Deep expertise in global PV regulations, safety surveillance, signal management, and risk management.
• Track record of health authority interactions, inspections, and audits.
• Excellent written, verbal, and presentation skills, with the ability to influence across functions and with external partners.

Responsabilidades

• Lead DS & PV and risk management activities for all programs, from first-in-human through late-stage development and registration.
• Provide safety medical oversight of surveillance and benefit-risk assessment, including medical review of ICsRs, signal detection and management, aggregate safety analyses, and risk mitigation strategies.
• Lead the company’s safety governance and, where applicable, support Data Safety Monitoring Committees.
• Serve as SME author, reviewer, and approver for safety content in regulatory submissions (DSUR, BLA/NDA, MAA), clinical study documents, labeling, Company Core Safety Information, and Risk Management Plans.
• Represent the company with health authorities, including presenting safety data and leading responses to safety questions, audits, and inspections.
• Ensure compliance with global PV regulations (FDA, EMA/EU GVP, ICH) as the company prepares for filings in the US, EU, and additional regions.
• Build the global DS & PV department, including operations, compliance, and medical functions, with dedicated safety leadership for each program as the portfolio grows.
• Establish scalable infrastructure: safety database and vendor strategy, SOPs, PV agreements, inspection readiness, and preparation for post-marketing obligations.
• Select and oversee external PV resources, including safety FSPs and consultants, and manage the DS & PV budget.
• Mentor and develop a high-performing team with a strong culture of safety, compliance, and operational excellence.
• Contribute to overall company strategy as a member of the senior leadership team.
• Partner with Clinical Development, Clinical Operations, Medical Affairs, Regulatory, Quality, and Biometrics to build safety thinking into program strategy early.

Conocimientos

Drug safety

Pharmacovigilance

Leadership

Regulatory knowledge

Cross-functional collaboration

Educación

MD

Descripción del empleo

Cornerstone Search Group, on behalf of a clinical-stage biotechnology company, seeks a Global Head of Drug Safety & PV to lead safety strategy and build the DS & PV function in the Boston/Cambridge area with hybrid work. This senior role reports to the Chief Medical Officer and sits on the leadership team.

You will shape global safety standards, drive regulatory submissions, establish scalable safety infrastructure, manage external resources, and mentor a high-performing team across programs.