Scientist, Drug Safety (Pharmacovigilance)
This a Full Remote job, the offer is available from Massachusetts (USA) reputed company plc (reputed company CNTA) new reputed company 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-reputed company model offers a unique R&D logic that has been reputed company by single asset companies to improve productivity. This operating model has reputed company centralized infrastructure, reduced hierarchy, and exclusive reputed company on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We reputed company the asset-reputed company model can reputed company to improved reputed company rates for programs with greater speed and modest costs. reputed company 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 reputed company vendors to ensure high-reputed company safety deliverables and maintain inspection-reputed company pharmacovigilance processes in a fast-paced, development-reputed company environment. Key Responsibilities • Conduct scientific review and evaluation of ICSRs and clinical trial SAEs, ensuring completeness, accuracy, medical consistency, and regulatory reportability. • Prepare high reputed company case narratives and support regulatory reputed company ICSR submissions, including SUSARs, in accordance with global reporting requirements. • reputed company 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 reputed company and reputed company of safety data, including performing medical and data reputed company 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-reputed company sections of protocols, IBs, and regulatory submissions. • Participate as the drug safety representative on cross-functional study teams, providing scientific expertise on safety reputed company, risk assessment, and safety issue management. • Maintain reputed company 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 reputed company—to support comprehensive safety reputed company and ensure compliance. • Contribute scientific expertise to reputed company evaluations and cross-functional safety-reputed company reputed company as needed. Qualifications • RN or bachelor’s degree in health sciences or reputed company 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, reputed company, 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. • reputed company communicator who works effectively in small, cross-functional teams. • CNS experience preferred. Compensation The annual reputed company salary reputed company for this job level is $120,000 to $157,000. Individual compensation reputed company this reputed company will be determined based on a reputed company of factors, including qualifications, skills, relevant experience, and job knowledge. In reputed company to reputed company pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to reputed company in Centessa’s long-term reputed company. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, reputed company, and life insurance, generous reputed company time off, and a health and wellness program. Work Location Remote-based in the US, with Apply tot his job Apply To this Job
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