Pharmacovigilance Operations Associate
On-site · Hyderabad, Telangana, India
Job Summary
Pharmacovigilance Operations Associate responsible for performing weekly review of literature articles from Embase, Medline, and BIOSIS to support signal detection and identification of ICSSRs for Amgen's portfolio. Key duties include literature management, determining criteria for ICSR/signal detection, deciding if full text should be ordered, flagging articles with new aggregate safety information for secondary review, translating non-English articles when needed, and supporting audits/inspections. Requires strong knowledge of pharmacovigilance processes/regulations, ability to manage competing priorities, and experience with literature citation management systems. Education: Master’s or Bachelor’s degree with 1–2 years of relevant literature review/safety experience; 1 year in pharma/biotech/regulatory setting preferred. Location: Hyderabad, India (onsite). Desired skills include literature screening, ICSR criteria identification, translation coordination, and familiarity with global literature surveillance practices.
Required Qualifications
- Master’s degree OR Bachelor’s degree with 1-2 years of literature screening/review or relevant Safety experience
- 1 year of pharmaceutical, biotech or regulatory authority experience in a research and development setting OR 1-2 years of literature screening/review or relevant Safety experience
- Knowledge of bibliographic databases and direct literature review experience preferred
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