Scientist - Drug Safety (Pharmacovigilance)

1w1 week ago

Centessa Pharmaceuticals plc

Boston, US · Full-time · $120,000 – $157,000

About this role

Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data-driven decision making led by subject matter experts. The company advances high conviction programs with strong biological validation using an asset-centric model. This Scientist, Drug Safety role supports pharmacovigilance activities across clinical-stage development programs.

Reporting to the Head of Safety and Pharmacovigilance, the role involves review and analysis of safety data for ongoing surveillance, regulatory compliance, and program execution. Daily tasks include scientific review of ICSRs and clinical trial SAEs, ensuring completeness, accuracy, and reportability. High-quality case narratives and regulatory submissions like SUSARs are prepared per global requirements.

The Scientist works closely with cross-functional partners and external vendors to deliver high-quality safety outputs. Participation as the drug safety representative on study teams provides expertise on safety strategy and risk assessment. Collaboration spans clinical development, operations, regulatory, and quality teams.

In this fast-paced, development-focused environment, processes remain inspection-ready with focus on data-driven capital allocation. The asset-centric model reduces hierarchy and incentivizes teams to interrogate scientific hypotheses expeditiously. Opportunities arise to contribute to ad-hoc safety projects and maintain knowledge of therapeutic areas and regulations.

Requirements

RN or bachelor’s degree in health sciences or related field required; Advanced Degree (PharmD, PhD strongly preferred)
5+ years of experience in drug safety in the biotech/pharmaceutical industry with 3+ years of pharmacovigilance compliance experience
Prior experience participating in Safety Risk Assessment Meetings / Safety Review activities required
Working knowledge of global PV regulations and guidelines (e.g., FDA, EMA, ICH, CIOMS)
Maintain current knowledge of therapeutic areas and industry best practices
Experience with scientific review of safety data and signal detection
Ability to perform medical review of individual case safety reports

Responsibilities

Conduct scientific review and evaluation of ICSRs and clinical trial SAEs, ensuring completeness, accuracy, medical consistency, and regulatory reportability
Prepare high quality case narratives and support regulatory ready ICSR submissions, including SUSARs, in accordance with global reporting requirements
Perform ongoing safety surveillance through analysis of adverse event data, identification of safety signals, and interpretation of emerging safety trends
Conduct literature surveillance to identify and evaluate safety findings relevant to company products and development programs
Ensure the scientific integrity and quality of safety data, including performing medical and data quality review of individual case safety reports
Support preparation, review, and scientific input into safety deliverables such as DSURs, line listings, Risk–Benefit assessments, and safety-related sections of protocols, IBs, and regulatory submissions
Participate as the drug safety representative on cross-functional study teams, providing scientific expertise on safety strategy, risk assessment, and safety issue management
Collaborate with cross-functional partners to support comprehensive safety oversight and ensure compliance