Vice President, Pharmacovigilance & Safety

Posted 13 Days Ago
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Boston, MA, USA
In-Office
350K-380K Annually
Expert/Leader
Healthtech • Pharmaceutical
The Role
The Vice President, Pharmacovigilance & Safety will provide strategic leadership in drug safety, overseeing global pharmacovigilance activities, and managing safety risk assessments and compliance across clinical development phases and post-marketing. This position involves collaboration with various teams and regulatory authorities.
Summary Generated by Built In

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.

Key Responsibilities

Strategic Leadership & Oversight 

  • 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. 
Qualifications 
  • 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.

Compensation

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 insurance, generous paid time off, and a health and wellness program.

Work Location

The Vice President, Pharmacovigilance and Safety role is based in the US, with occasional travel.

POSITION: Full-Time, Exempt

EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.

Skills Required

  • Medical Degree (MD) in a life science-related field
  • 15+ years of pharmacovigilance experience in the biopharmaceutical industry
  • 10+ years in senior leadership roles
  • Experience supporting CNS drug development programs
  • Extensive experience in small molecule drug development (Phase 1-Phase 4)
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The Company
Altrincham
83 Employees
Year Founded: 2023

What We Do

Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company with a Research & Development innovation engine that aims to discover, develop and ultimately deliver impactful medicines to patients. Our programs span discovery-stage to late-stage development and cover a range of high-value indications in rare diseases and immuno-oncology. We are led by a management team with extensive R&D experience, providing direct guidance to our program teams to rapidly advance our candidates from research through all stages of development. We are headquartered in Boston, Massachusetts

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