Job Description
Vacancy for Drug Safety Specialist at Wipro.
Job Title/Position:
Drug Safety Specialist
Job Overview:
Job vacancy for Pharmacy
What are the Key Responsibilities?
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
What are the Educational Qualification(s) for this position(s)?
M.Pharm / B.Pharma / BAMS / BHMS / PhD./ Pharm D / BDS
What are the Preferred Skills required for this Job/Position?
1) Sound knwoledge of regulatory guidelines related to PV domain
2) Narrative Writing
3) MedDRA Coding
4) Familiarity with pharmacological concepts
5) Command on verbal and written communication skills
6) Team Player
Related:
Vacancy for Drug Safety Associate at Clario
