Dr. Reddy's Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products - Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets.
Job Title: Drug Safety Associate, Clinical Development
Qualification: M.Sc/ M.Tech - Bio-Chemistry/Bio-Technology/ Microbiology / Chemistry
Experience: 1-3 years
Job Description:
- Assimilate information on adverse events, perform initial checks, update safety data tracking tool, do case validation, preliminary assessment of case reportability and create case report file.
- Ensure complete and consistent data entry of adverse event reports from source documents with acceptable timeline and quality.
- Manage handling of non-expeditable AE reports, legacy AE reports including review for completeness and accuracy.
- Use medical dictionaries and business guidance to check correct coding of medical history, drugs and adverse event terms.
- Identify clinically relevant information missing from case report and facilitate its collection (from medical team) to generate appropriate follow-up request as needed.
- Alert manager about important safety concerns based on preliminary case reports.
How to Apply:
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