Veterinary Doctor

Division
- PHARMACOVIGILANCE
- Job posted on
- Feb 5, 2023
- Employee Type
- C-C8-Confirmed-HO Executive
- Experience range Range (Years)
- 0 - 10 years

**Job description **(major role)**:

- Prepare and maintain periodic reports schedule.
- Generate line listing/safety data for preparation of Periodic Safety Update Reports (PSURs)/Periodic Adverse Drug Experience Reports (PADERs)/Risk Management Plan (RMP)/other periodic report, as required.
- Quality check for processed cases.
- Case assignment, conducting team huddle, presentation.
- Processing of literature, spontaneous, regulatory, and partner’s serious and non-serious cases.
- Identification and coding of adverse events and product quality issue (PQC) from report. Coding of adverse events in clinical safety database.
- Initiation and book-in of all the adverse event reports received
- Prioritize and process the cases retrieved/received from various sources like spontaneous, literature, regulatory, clinical studies/trials, BA/BE studies etc.
- Coding of events using the latest version of VeDDRA and causality assessment of the reported events.
- Evaluation of the expectedness of the events by referring the latest PIs/SPCs/RSI/IBs.
- Writing the safety narrative.
- Perform follow-up with the reporter/author/concerned stake holder(s), as and when required.
- Coordinate with medical information contact center for collecting the follow-up information, as and when required.
- Quality review of the cases entered in the database for its quality and completeness.
- Submission of the eligible cases to regulatory agencies.
- Sharing of the eligible cases with concerned stake holder(s), as and when required.
- Attach/upload the acknowledgements of ADEs in the global safety database.
- Resolve the queries related to the case processing activities.
- Update various logs/trackers related to case processing activities.