Global VP, Drug Safety & Pharmacovigilance

Hemab Therapeutics; Massachusetts; On-site; USD 300,000 - 450,000; Full time

Job summary

Hemab Therapeutics, a clinical-stage biotech company with bases in Cambridge, MA, USA and Copenhagen, Denmark, seeks a transformative leader to serve as Vice President, Global Head of Drug Safety and Pharmacovigilance. You will shape safety strategy, build a scalable safety system, and lead cross-functional teams across early and late-stage programs.

Reporting to the CMO, you will oversee DS & PV operations, regulatory compliance, risk management, and external partnerships while guiding safety

Qualifications

• MD and 10+ years of drug safety, pharmacovigilance, risk management, or related roles within the pharmaceutical/biotech industry.
• Experience as prior Head of DS & PV, with late-stage clinical development and with BLA/NDA/MAA submissions highly preferred.
• Strong leadership skills with a proven record of building and managing safety teams, including operational and compliance functions.
• Expertise in global PV regulations, safety surveillance, and risk management strategies.
• Experience with regulatory authority interactions and safety signal management.

Responsibilities

• Lead and oversee Hemab DS & PV as well as risk management activities for all programs.
• Strategically lead the development of Hemab’s DS & PV department, including operations, compliance and medical functions, based on industry best practices.
• Mentor and develop a high-performing DS & PV team, fostering a culture of safety, compliance, and operational excellence.
• Participate as a core member of Hemab’s senior leadership team, contributing to overall company strategy.
• Develop and manage DS & PV budgets, ensuring alignment with corporate objectives.
• Collaborate cross-functionally with Clinical, Medical Affairs, Regulatory, Quality, Biometrics and other teams to drive safety initiatives.
• Ensure compliance with global pharmacovigilance regulations (FDA, EMA, ICH, EU GVP, and other relevant agencies).
• Manage and oversee internal and external PV resources, including safety functional service providers and consultants.
• Develop processes for and provide safety medical oversight of safety surveillance and benefit risk assessments, including medical review of IC SIDS, signal management activities, safety analyses, benefit risk profile development and monitoring, and risk mitigation strategies.
• Ensure that aggregate data safety signals are identified promptly and communicated appropriately, including oversight of use of signal detection tools and other sources of product signals.
• Participate in and lead Hemab’s safety governance meetings and, where applicable, data safety monitoring committees.
• Serve as SME author, reviewer, and approver for drug-safety related regulatory submissions (DSUR, BLA, NDA, MAA), clinical study documents (Clinical Study Protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), labeling, Company Core Safety Information, etc.) and risk management plans.
• Lead responses to safety questions from regulatory authorities, audits, and inspections while ensuring corrective actions are effectively implemented.
• Represent Hemab in interactions with health authorities, including preparing and presenting safety data in regulatory meetings, and public presentations.

Skills

Leadership

Drug Safety

Pharmacovigilance

Regulatory Affairs

Cross-functional

Budget Management

Education

MD

Job description

Hemab Therapeutics, a clinical-stage biotech company with bases in Cambridge, MA, USA and Copenhagen, Denmark, seeks a transformative leader to serve as Vice President, Global Head of Drug Safety and Pharmacovigilance. You will shape safety strategy, build a scalable safety system, and lead cross-functional teams across early and late-stage programs.

Reporting to the CMO, you will oversee DS & PV operations, regulatory compliance, risk management, and external partnerships while guiding safety