Role and responsibilities Perform case processing and safety data entry for Individual Case Safety Reports (ICSRs) Review and assess adverse event reports received from clinical trials, spontaneous sources, literature and other channels Perform data entry, medical coding, narrative writing and case follow-up as per standard procedures Conduct seriousness, expectedness and causality assessments based on applicable guidelines and company procedures Perform Med DRA coding for adverse events and WHO Drug coding for medicinal products Ensure accurate and timely processing of safety cases within defined timelines Support quality checks and reconciliation of safety data Maintain proper documentation and compliance with pharmacovigilance SOPs and regulatory requirements Assist with safety databases such as Argus Safety and other PV systems Support preparation of safety reports and other pharmacovigilance-related documentation Preferred candidate profile Bachelor's or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Microbiology, Nursing, Medicine or a related healthcare discipline Freshers and candidates with relevant pharmacovigilance experience may apply Basic understanding of Pharmacovigilance, Drug Safety, ICSR, Adverse Events and Clinical Research Knowledge of Med DRA coding, WHO Drug coding and safety case processing is preferred Familiarity with Argus Safety or other pharmacovigilance databases is an advantage Good written and verbal communication skills Strong attention to detail and analytical skills Ability to understand medical terminology and review clinical information accurately Willingness to work within defined regulatory timelines and quality standards Good working knowledge of MS Office, particularly Word and Excel #J-18808-Ljbffr
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