Safety Associate Lead

5 days ago


Pune, Maharashtra, India beBeeAssociate Full time ₹ 90,00,000 - ₹ 1,20,00,000
Job Role

We are looking for a skilled professional to fill the role of Safety Associate Lead. The selected candidate will be part of our Pharmacovigilance team and play a crucial part in meeting project deadlines.

Main Responsibilities:
  • Support case management projects by collecting Adverse Events, tracking cases through processing activities, and coordinating workflow.
  • Triage AEs to determine reportability, assess expectedness, seriousness, and causality according to regulatory guidelines and product safety information.
  • Code adverse events using clinical judgment and medications with WHODRUG.
  • Perform quality control checks on the safety database and regulatory reporting forms for completeness, accuracy, and consistency.
Key Requirements:
  • Bachelor's degree in a life science field, preferably pharmacy or nursing.
  • At least 5 years of relevant experience, including 3 years in drug safety.
  • Strong knowledge of domestic and international drug safety regulations, industry practices, and standards.
  • Attention to detail, teamwork, and initiative are essential skills.
PREFERRED QUALIFICATIONS:
  • Familiarity with FDA and international adverse event reporting regulations per ICH guidelines.
  • Understanding of medical terminology and principles of adverse event reporting in the pharmaceutical industry.


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