Senior Scientist - Drug Safety (Pharmacovigilance)

1w1 week ago

Centessa Pharmaceuticals plc

Boston, US · Full-time · $145,000 – $190,000

About this role

Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a deconstructed R&D environment prioritizing data-driven decision making led by subject matter experts. The asset-centric model offers unique R&D logic with minimal centralized infrastructure and reduced hierarchy. We seek a Senior Scientist to support pharmacovigilance across clinical-stage programs.

This role involves reviewing and analyzing safety data for ongoing surveillance, regulatory compliance, and program execution. Responsibilities include oversight of ICSR and SAE evaluation, development of case narratives, and aggregate data analysis to identify emerging signals. The position ensures high-quality safety deliverables in a fast-paced environment.

Reporting to the Head of Safety and Pharmacovigilance, the Senior Scientist collaborates with cross-functional partners and external vendors. Serve as lead safety representative on study teams, influencing strategy and decision-making. Work closely with clinical development, operations, regulatory, and quality teams for alignment.

Centessa's teams are incentivized to interrogate scientific hypotheses expeditiously, focusing on data-driven capital allocation. Contribute senior scientific input to DSURs, protocols, and submissions while maintaining inspection-ready processes. Opportunities include leading safety projects and applying expertise to portfolio priorities.

Requirements

PharmD or PhD in scientific field
6+ years of experience in drug safety or pharmacovigilance
Advanced knowledge of ICSR processing and SAE evaluation
Expertise in safety signal detection and risk-benefit assessment
Familiarity with global regulations including FDA, EMA, ICH, and CIOMS
Experience preparing DSURs, SUSARs, and safety sections for submissions
Ability to interpret literature and aggregate safety data
Strong scientific review skills for complex pharmacovigilance cases

Responsibilities

Provide advanced scientific oversight of ICSR and clinical trial SAE evaluation, ensuring medical accuracy, regulatory reportability, and consistency
Lead development of high-quality case narratives and guide scientific preparation of regulatory ready case submissions, including SUSARs
Drive ongoing safety surveillance by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk-benefit assessments
Oversee literature surveillance to identify new safety information, interpret clinical relevance, and communicate findings to stakeholders
Ensure scientific integrity and quality of safety data through expert review of complex cases and mentorship of junior team members
Provide senior level scientific input into DSURs, line listings, safety summaries, and safety sections of protocols and submissions
Serve as lead drug safety representative on cross-functional study teams, shaping safety strategy and advising on issue management
Collaborate with clinical, regulatory, and quality partners to provide scientific leadership on safety topics