Clinical Pharmacovigilance Specialist
5 days ago
Lifelancer, a leading talent-hiring platform in Life Sciences and Pharma, is seeking an experienced Clinical Pharmacovigilance Specialist to join our esteemed clients' team. This role presents a unique opportunity to work with cutting-edge biopharmaceuticals, driving innovative therapies for patients worldwide.
About the CompanyCullinan Therapeutics, Inc. (Nasdaq: CGEM) is a pioneering biopharmaceutical company dedicated to revolutionizing patient care through groundbreaking treatments. With a diverse portfolio of clinical-stage assets, they are pushing boundaries in oncology and autoimmune disease research.
About the RoleWe are looking for a seasoned Professional to lead our safety strategies, ensuring timely aggregation, review, and analysis of critical safety data. As a key member of our cross-functional teams, you will develop PV/Safety documents, working closely with medical, clinical operations, regulatory affairs, and translational sciences departments.
Responsibilities:- Lead Cullinan product life-cycle support for assigned products, participating in clinical study team meetings as needed.
- Represent PV on cross-functional teams, including Cullinan Safety Management Team (SMT), Independent Data Monitoring Committees (IDMC), and other external teams.
- Perform signal detection activities for assigned products, adhering to approved safety surveillance plans.
- Analyze safety data, prepare presentations for SMT meetings, and author safety evaluation reports.
- Alert Head of PV and Medical Safety Physicians to potential safety concerns identified through single case medical review or aggregated data sets.
- Author, prepare, and review safety documents, including DSUR, PSUR, RMP, responses to health authorities, and other stakeholder queries.
- Participate in risk management/mitigation activities for assigned compounds.
- Collaborate with Clinical/Medical function in protocol development and ensure safety oversight.
- M.S., Ph.D., or Pharm.D. degree required.
- A minimum of 5 years of experience in pharmaceutical/biotech industry or health authority, preferably in PV/drug safety and risk management.
- Demonstrated passion, dedication, and can-do attitude towards a career in PVS.
- Excellent written and verbal communication skills.
- Proficiency in utilizing safety system databases for medical case review and simple queries.
- Knowledge of current and emerging regulatory requirements, including EMA GVP Modules, FDA IND/NDA reporting, global risk management, ICH, CIOMS.
- Prior experience in medical oncology and/or immunology is preferred.
- Ability to effectively present to cross-functional teams is essential.
$120,000 - $180,000 per annum, commensurate with qualifications and experience.
About LifelancerLifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT, connecting professionals with opportunities across various domains. We strive to create an inclusive environment, promoting diversity and equal opportunities for all applicants.
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Cambridge, Massachusetts, United States Lifelancer Full timeJob OverviewCullinan Therapeutics is a pioneering biopharmaceutical company focused on revolutionizing patient care through the development of transformative therapeutics in oncology and autoimmune disease.Key ResponsibilitiesThe Pharmacovigilance Scientist will play a critical role in the development and planning of safety strategies for assigned products,...
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