Pharmacovigilance (Case Processing)

2 weeks ago


Ahmedabad, India Zydus Group Full time

Division
- PHARMACOVIGILANCE
- Job posted on
- Jan 10, 2023
- Employee Type
- P-P8-Probationer-HO Executive
- Experience range Range (Years)
- 3 years - 7 years

**Job description**:

- Perform duplicate search in the global safety database and/or various logs/trackers using all possible/multiple criteria to identify the duplicate(s) of existing ICSR(s).
- 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 MedDRA 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 ICSRs in the global safety database.
- Resolve the queries related to the case processing activities.
- Update various logs/trackers related to case processing activities.
- Impart training on case processing activities to concerned stake holder(s), as and when required.
- Perform all other pharmacovigilance activities as assigned by HoD-GPV.


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