Develop and execute a comprehensive pharmacovigilance (PV) strategy aligned with corporate objectives and regulatory expectations.
Lead safety governance and benefit-risk management for small molecule assets across development and post-marketing.
Ensure compliance with global PV regulations (FDA, EMA, ICH, MHRA, etc.).
Provide strategic safety input into clinical trial designs, protocols, and regulatory submissions .
Establish and oversee PV partnerships, vendors, and external collaborations .
Operational & Regulatory Compliance
Lead the safety surveillance and signal detection process , ensuring timely identification and mitigation of safety risks.
Oversee the preparation and submission of safety reports (e.g., DSURs, PSURs, RMPs, SUSARs, IND safety reports, 15-day alerts) .
Ensure robust case processing, signal evaluation, and risk management processes are in place.
Represent the company in regulatory interactions regarding safety matters (FDA, EMA, etc.).
Cross-Functional Collaboration
Work closely with Clinical Development, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams to integrate safety considerations into decision-making.
Partner with Regulatory Affairs to support new drug applications (NDAs) and marketing authorizations.
Support DSMBs, advisory boards, and investigator meetings with safety expertise.
Team Leadership & Development
Build and lead a high-performing pharmacovigilance team , fostering a culture of scientific excellence and compliance.
Provide mentorship and guidance to internal safety professionals.
Requirements
Medical Degree (MD) in a life science-related field is required.
15+ years of pharmacovigilance experience in the biopharmaceutical industry, including 10+ years in senior leadership roles.
Demonstrated experience supporting CNS drug development programs across clinical and post-marketing stages.
Extensive experience in small molecule drug development (Phase 1-Phase 4).
Proven track record of effective interactions with global health authorities on safety-related matters.
Deep understanding of global pharmacovigilance regulations, GVP, and ICH guidelines.
Demonstrated ability to lead safety risk management strategies, signal detection, and benefit-risk assessments.
Experience leading cross-functional safety teams and influencing stakeholders in a fast-paced biotech environment.
Expertise in clinical trial safety oversight, post-marketing pharmacovigilance, and regulatory safety submissions.
Strong analytical judgment, decision-making, and problem-solving capabilities.
Excellent written and verbal communication skills with the ability to engage senior internal and external stakeholders.
Ability to thrive in a dynamic, high-growth organization.
Benefits
The annual base salary range for this position is $350,000.00 to $380,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge.In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life inHealth insuranceDental insuranceVision insurance401(k)Performance bonus
Additional Information
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation.
Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.
Description of Role
The Vice President, Global Medical Safety / Pharmacovigilance will serve as the global leader for drug safety, providing strategic vision and medical oversight across all pharmacovigilance and risk management activities. This role is responsible for leading pre- and post-marketing safety activities across all phases of clinical development (Phase I-IV) and post-approval, ensuring proactive benefit-risk assessments, regulatory compliance, and the highest standards of patient safety. The VP will drive an integrated, science-driven global safety strategy for the company's small molecule pipeline, working closely with internal stakeholders and teams, as well as global health authorities. In addition, this role will oversee departmental operations, including organizational planning, budgeting, and the development of scalable pharmacovigilance capabilities to support a growing biotech organization.
Centessapharmaceuticalsinc · Boston, MA