Scientist, Drug Safety (Pharmacovigilance) jobs in United States
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Centessa Pharmaceuticals · 16 hours ago

Scientist, Drug Safety (Pharmacovigilance)

Centessa Pharmaceuticals plc is a new kind of pharmaceutical company with a focus on data-driven decision making. The Scientist, Drug Safety (Pharmacovigilance) will support pharmacovigilance activities, contributing to safety data analysis, regulatory compliance, and collaboration with cross-functional partners to ensure high-quality safety deliverables.

BiotechnologyPharmaceutical
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H1B Sponsor Likelynote

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 across investigational and marketed products
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
Maintain current knowledge of therapeutic areas and global drug safety regulations, guidelines, and industry best practices (e.g., FDA, EMA, ICH, CIOMS)
Collaborate with cross-functional partners—including clinical development, clinical operations, regulatory, medical writing, and quality—to support comprehensive safety oversight and ensure compliance
Contribute scientific expertise to ad-hoc evaluations and cross-functional safety-related projects as needed

Qualification

Pharmacovigilance complianceGlobal PV regulationsSafety Risk AssessmentPV databasesAnalytical skillsClear communicatorCNS experienceAttention to detail

Required

RN or bachelor's degree in health sciences or related field required
5+ years of experience 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 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

Advanced Degree (PharmD, PhD strongly preferred)
Experience with PV databases and safety surveillance tools (e.g., Argus, ArisGlobal, Vault Safety); familiarity with MedDRA coding preferred
CNS experience preferred

Benefits

Discretionary annual bonus
Participation in our equity program
401(k) plan
Company-sponsored medical, dental, vision, and life insurance
Generous paid time off
Health and wellness 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