Essential Duties and Responsibilities:
As Case Intake Member:
- Responsible for case intake, duplicate check, and registration
- Maintain log of source documents and other communications
- As Case Processor:
- Responsible for data entry of individual case safety reports into the safety database.
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures
- Process all incoming cases in order to meet timelines
- Full data entry including medical coding and safety narrative
- As Medical Coder
- Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)
- As Narrative Writer
- Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
- As Literature Review Specialist
- Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.




- Review of literature articles to identify case safety reports.
- Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
- Assist in signal generation and safety analysis activities.
- Ensure quality of literature searches and reporting.
- Review of local/global literature reports to determine regional reportability.
- Create/maintain study summary documents.
- Assist with narrative writing for periodic/ad hoc submissions.
- Assist with ad hoc or routine safety monitoring activities.
- Other Responsibilities:
- Following up with sites regarding outstanding queries.
- Follow up on reconciliation of discrepancies.
- Follow departmental AE workflow procedures
- Closure and deletion of cases
- Perform any other drug safety related activities as assigned

Specialized knowledge and skills:
- Basic competence with medical and therapeutic terminology.
- A

📌 Jr. Drug Safety Associate (Mysuru)
🏢 Clario
📍 Mysuru