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Scientist, Drug Safety (Pharmacovigilance)
Location
United States
Posted
96 days ago
Salary
$120K - $157K / year
Seniority
Mid Level
Job Description
Scientist, Drug Safety (Pharmacovigilance)
Centessa Pharmaceuticals, LLC
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 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 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. Key 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. Qualifications - RN or bachelor’s degree in health sciences or related field required. Advanced Degree (PharmD, PhD strongly preferred). - 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. - CNS experience preferred. Compensation The annual base salary range for this job level is $120,000 to $157,000. 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. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. Work Location Remote-based in the US, with <10% travel to headquarters in Boston, MA. POSITION: Full-Time, Exempt EEOC 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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.
Job 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 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.
- The annual base salary range for this job level is $120,000 to $157,000. 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.
- Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.
- Work Location
- Remote-based in the US, with <10% travel to headquarters in Boston, MA.
- Full-Time, Exempt
- EEOC 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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
- Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.
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