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.
Designation Pharmacovigilance Associate –
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.
Work with drug safety team to ensure high compliance for end to end ICSR management.
Work with drug safety team in various safety data related administrative and procedural activities as required or requested.
Good understanding and experience of adverse event cases processing (ISCRs) from various sources such as Spontaneous, Post marketing surveillance Studies, Published Medical Literature, Health Authority/ Legal notification & Clinical Trials etc.
This includes primarily, case processing, coding of events, medical history and drugs, narrative writing etc.
Familiarity and general understanding of medical terminology, experience in working with medical dictionaries (MedDRA & WHO DDE).
Good understanding of different pharmacovigilance processes such as ICSR management, aggregate report management, knowledge of pharmacovigilance Global and local regulatory reporting requirements, etc.
Experience with working on Global standard safety data bases such as ARISg and/or Argus safety.
Experience 1 – 2 Years
UG – Any Graduate – Any Specialization, Graduation
PG – M.Sc – Any Specialization, Agriculture, Anthropology, Bio-Chemistry, Biology, Botany, Microbiology, Zoology, M.Tech – Bio-Chemistry/Bio-Technology, Agriculture, Biomedical, M.Pharma – Pharmacy
Location: Hyderabad / Secunderabad
Keywords: adverse event case processings, ISCRS