Sr. Scientist, Drug Safety (Pharmacovigilance) jobs in United States
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Centessa Pharmaceuticals · 12 hours ago

Sr. Scientist, Drug Safety (Pharmacovigilance)

Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data-driven decision making. They are seeking a Senior Scientist in Drug Safety (Pharmacovigilance) to support pharmacovigilance activities across their clinical-stage development programs, ensuring high-quality safety deliverables and maintaining inspection-ready processes.

BiotechnologyPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

PharmDPhDDrug safety experiencePharmacovigilance complianceGlobal PV regulationsSafety surveillance toolsAnalytical skillsClear communicatorCNS experienceAttention to detail

Required

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
Prior experience facilitating in Safety Risk Assessment Meetings / Safety Review activities required
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

Preferred

CNS experience preferred

Benefits

Discretionary annual bonus
Participation in our equity program

Company

Centessa Pharmaceuticals

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Centessa Pharmaceuticals is a next-generation biopharmaceutical company that aims to reshape the traditional drug development process.

H1B Sponsorship

Centessa Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)

Funding

Current Stage
Public Company
Total Funding
$1.12B
Key Investors
Oberland Capital
2025-11-11Post Ipo Equity· $250M
2024-09-11Post Ipo Equity· $225M
2024-04-23Post Ipo Equity· $100M

Leadership Team

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John Crowley
Chief Financial Officer
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Gregory Weinhoff
Chief Business Officer
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Company data provided by crunchbase