Clinical Pharmacovigilance Specialist

8 hours ago


Cambridge, Massachusetts, United States Lifelancer Full time
Senior Position in Pharmaceutical Safety

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 Company

Cullinan 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 Role

We 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.
Requirements:
  • 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.
Estimated Salary Range:

$120,000 - $180,000 per annum, commensurate with qualifications and experience.

About Lifelancer

Lifelancer 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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