Provide advanced scientific oversight of ICSR and clinical trial SAE evaluation, ensuring medical accuracy, regulatory reportability, and consistency across global development programs.
Lead the development of high-quality case narratives and guide the scientific preparation of regulatory ready case submissions, including SUSARs, in alignment with global reporting requirements.
Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk-benefit assessments for investigational and marketed products.
Oversee literature surveillance to identify new or evolving safety information, interpret clinical relevance, and communicate findings to cross-functional stakeholders.
Ensure the scientific integrity and quality of safety data through expert review of complex cases and mentorship of junior team members in case assessment and safety data interpretation.
Provide senior level scientific input into the preparation and review of DSURs, line listings, safety summaries, and safety-related sections of protocols, Investigator's Brochures, and regulatory submissions.
Serve as the lead drug safety representative on cross-functional study teams, shaping safety strategy, influencing program decision-making, and advising on safety issue management.
Maintain expert level knowledge of therapeutic areas and global drug safety regulations, guidelines, and evolving best practices (e.g., FDA, EMA, ICH, CIOMS), and apply this expertise to program decisions and safety governance.
Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners to provide scientific leadership on safety topics and ensure alignment on safety strategy and interpretation.
Lead or contribute to complex, cross-functional safety projects, safety signal evaluations, and ad-hoc scientific analyses to support portfolio needs and organizational priorities.
Requirements
PharmD or PhD in scientific field
6+ years of experience of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience.
Working knowledge of global PV regulations and guidelines applicable to clinical development (e.g., FDA, EMA, ICH, GCP).
Experience with PV databases and safety surveillance tools (e.g., Argus, ArisGlobal, Vault Safety); familiarity with MedDRA coding preferred.
Experience supporting clinical safety case processing and aggregate reporting.
Strong analytical skills, attention to detail, and comfort working across multiple programs.
Clear communicator who works effectively in small, cross-functional teams.
CNS experience preferred.
Benefits
The annual base salary range for this job level is $145,000 to $190,000. 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 and participation in our equity program, allowing you to share in Centessa's long-term success.Work LocationRemote-based in the US, withPOSITION: Full-Time, ExemptEEOC 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 otherRemote work optionsEquity / stock optionsPerformance 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
We are seeking a Senior Scientist, Drug Safety (Pharmacovigilance) to support pharmacovigilance activities across Centessa's clinical-stage development programs. Reporting to Centessa's Head of Safety and Pharmacovigilance, this role will contribute to the review and analysis of safety data to support ongoing safety surveillance, regulatory compliance, and program execution. The Senior Scientist will work closely with cross-functional partners and external vendors to ensure high-quality safety deliverables and maintain inspection-ready pharmacovigilance processes in a fast-paced, development-focused environment.
Centessapharmaceuticalsinc · Boston, MA