Job as Drug Safety Associate at Wipro

At Wipro, the safety, health and well being of our employees is of paramount importance and over the past several weeks we have taken a series of preventive measures to protect our employees from the Coronavirus outbreak. Given the evolving situation, we have advised our employees to work from home wherever feasible and if their role allows them to do so. Wipro offices will remain open. Our global Environment, Health & Safety (EHS) and crisis management teams will continue to assess the situation, review these measures after a week and decide the future course of action.

Post : Drug Safety Associate (Case Processor)

Job Description
1. Reviewing the published reports/ biomedical literature to ascertain if they contain a case report of an adverse reaction and Non-individual case reports.
2. Applying regulatory and internal guidance to determine if the article meets the definition of a 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 timelines.
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.
7. To contribute/support the project through query resolution of peer team members.
8. To perform other responsibilities delegated by the team lead/manager.

Candidate Profile
Qualification - M. Pharm / B.Pharm / BAMS / BHMS / Pharm.D / BDS
Experience - 0 - 7 Years in PV.

Technical / Functional Competency :
1. Sound knowledge of regulatory guidelines related to PV domain.
2. Narrative Writing
3. MeDRA Coding
4. Sound knowledge of Pharmacological concepts
5. Command on Verbal and Written communication skills.
6. Team player

Additional Information
Experience : 0 - 7 Years
Qualification : M. Pharm / B.Pharm / BAMS / BHMS / Pharm. D / BDS
Location : Pune
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 5th October, 2023