Wipro Pune looking for Drug Safety Specialist
About the job
Job Description: 1. Reviewing the published reports/biomedical literature to ascertain if they contain individual case reports and Non-individual case reports.
2. Applying regulatory and internal guidance to determine if the article meets the definition of a valid case report and Non- individual case reports.
3. Write accurate and concise summaries that capture the key elements from these published reports
4. Ensure consistent coding of medical history, drugs and adverse event terms
5. Evaluation of Serious Adverse Event to ensure accurate processing from source documents with emphasis on quality and timeliness
6. Creating summary content in a range of formats (narrative summaries, structured database inputs, electronic formats for regulatory filing) to support the drug safety reporting and information requirements of pharma industry client
Qualification: M.Pharm / B. Pharma / BAMS / BHMS / PhD./ Pharm D / BDS