Safety Writer
1 day ago
Hyderabad 3 to 5 years Full Time
**Department**:
Pharmacovigilance
**Education Qualification**:
Graduate/Post Graduate/Doctorate degree in Life Sciences/Pharmacy/Medical Sciences or equivalent degree. Fluency in English.
**Mode of work**:
On premise
- Serves as Advity’s primary contact and expert for aggregate reports
- Interacts and communicates effectively internally and cross-functionally in a highly matrixed environment.
- Draft, Retrieve and analyse the safety data from global safety database and ensure adequate presentation in the ARs (PADER/PSUR/PEBRER/RMP/DSUR/ADco’s).
- Ensure a comprehensive and consistent aggregate analysis performed to establish the risk benefit profile of the product that meets all HA requirements.
- Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety Physicians in monitoring the safety profile of products.
- Support independent QC of ARs to ensure the information presented in AR is complete, consistent and compliant to regulatory and Advity standards. Adhere to good documentation practices to ensure audit/inspection readiness.
- 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.
- Support Health Authority inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings.
- Responsible to be informed with the current global PV regulatory requirements.
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