Pharmacovigilance Associate...Dr.Reddy's Laboratory Ltd...h8

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Pharmacovigilance Associate - 1 Opening(s)
Job Description	1. 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. 2. Ensure complete and consistent data entry of adverse event reports from source documents with acceptable timeline and quality. 3. Manage handling of non-expeditable AE reports, legacy AE reports including review for completeness and accuracy. 4. Use medical dictionaries and business guidance to check correct coding of medical history, drugs and adverse event terms. 5. Identify clinically relevant information missing from case report and facilitate its collection (from medical team) to generate appropriate follow-up request as needed. 6. Alert manager about important safety concerns based on preliminary case reports. 7. Work with drug safety team to ensure high compliance for end to end ICSR management. 8. Work with drug safety team in various safety data related administrative and procedural activities as required or requested. Professional requirement: 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.
Desired Profile	Please refer to the Job description above
Experience	1 - 2 Years
Industry Type	Pharma / Biotech / Clinical Research
Role	Documentation/Medical Writing
Functional Area	Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Education	UG - Any Graduate - Any Specialization, Graduation Not Required  PG - M.Sc - Any Specialization, Agriculture, Anthropology, Bio-Chemistry, Biology, Botany, Microbiology, Zoology, M.Tech - Bio-Chemistry/Bio-Technology, Agriculture, Biomedical, M.Pharma - Pharmacy  DOCTORATE - Doctorate Not Required
Location	Hyderabad / Secunderabad
Keywords	adverse event case processings, ISCRS
Contact	Talent Acquisition Team  Dr Reddys Laboratories Ltd
Website	http://www.drreddys.com
Job Posted	01 Jul