VP, Global Head of Drug Safety & Pharmacovigilance
Description
TITLE: Vice President, Global Head of Drug Safety (DS) & Pharmacovigilance (PV)
REPORTS TO: Chief Medical Officer
TEAM: Builds and leads the global DS & PV function (operations, compliance, and safety medical), with FSP and consultant partners
LOCATION: Boston/Cambridge, MA area (hybrid) preferred. Other US and international locations considered for the right candidate.
LEADERSHIP: Member of the company’s senior leadership team
ABOUT OUR CLIENT
Our client is a well-funded, clinical-stage biotechnology company developing novel biologic therapies for serious diseases with high unmet medical need. It has multiple programs in the clinic, with its lead program advancing into late-stage, pivotal development.
The company has US and international operations and a strong financial position. It is building the leadership team that will take it from clinical-stage to a global, late-stage, and pre-commercial organization.
THE OPPORTUNITY
As our client’s lead program moves into pivotal development, with more programs following and global filings on the horizon, safety leadership has become a strategic priority. The company is appointing a Global Head of DS & PV to own the function and build it for the long term.
Reporting to the Chief Medical Officer and serving on the senior leadership team, the Global Head of DS & PV will set safety strategy across the portfolio. You will build a fit-for-purpose safety system that scales from late-stage development through registration and commercialization, and grow a team designed to provide dedicated safety leadership for each program.
WHY THIS OPPORTUNITY
- A chance to shape and build a global safety function the right way.
- A seat on the senior leadership team at a company moving toward global registration.
- Meaningful work for patients with serious diseases and limited treatment options.
- A well-capitalized company with the resources to invest in its leadership team.
Location
Boston/Cambridge, MA area (hybrid) preferred. Other US and international locations considered for the right candidate.
Responsibilities
KEY RESPONSIBILITIES
Safety Strategy & Medical Oversight
- 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.
Regulatory & Submissions
- 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.
Building the Function
- 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.
Cross-Functional Leadership
- 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.
Qualifications / Requirements
QUALIFICATIONS & EXPERIENCE
Required
- 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.
Preferred
- Experience with biologics.
- Rare disease or specialty therapeutic area experience.
- Experience taking a safety organization from clinical-stage through approval and into commercial readiness.
- Global PV experience across US and EU requirements, plus exposure to other ex-US markets.
LEADERSHIP ATTRIBUTES
- Patient-centered: treats safety as a direct expression of the company’s commitment to patients.
- Hands-on builder: strategic enough to design the function and practical enough to run it while it is being built.
- Curious and rigorous: questions data, anticipates risk, and holds high standards of scientific and ethical integrity.
- Collaborative partner: brings safety perspective early and constructively, across teams and time zones.
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