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Pharmacovigilance Associate
2 weeks ago
**Primary Responsibilities**:
1. General Responsibilities and Regulatory Compliance:
- Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File).
- Monitor national pharmacovigilance legislation.
- Ensure appropriate interpretation and implementation of national pharmacovigilance regulation for both
drugs and devices.
- Responsible for liaising with the Ministry of Health (MoH)/national regulatory authority (RA), work with legal, quality, medical and regulatory on safety issues if necessary.
- Responsible for appropriate communication between product safety locally, Global Patient Safety (GPS), and other relevant stakeholders (product complaints, medical and regulatory affairs).
- Has awareness and provides input to local Risk Management Plans, local risk minimization activities and local Post Safety Authorization Studies as applicable.
- Ensure local business alliance and third-party safety agreements are in place, up to date and followed as required.
- Provide local training (initial and/or refresher) for employees and/or business alliance partners to raise the awareness of PhV, as required.
**Salary**: ₹18,000.00 - ₹45,000.00 per month
**Benefits**:
- Cell phone reimbursement
- Work from home
Schedule:
- Day shift
Supplemental pay types:
- Joining bonus
- Performance bonus
