Pharmacovigilance Associate
1 week 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.
**Job Types**: Full-time, Regular / Permanent, Fresher
**Salary**: ₹286,059.71 - ₹1,250,090.43 per year
**Benefits**:
- Health insurance
- Provident Fund
- Work from home
Schedule:
- Day shift
- Morning shift
- Rotational shift
Supplemental pay types:
- Performance bonus
- Yearly bonus
**Speak with the employer**
+91 8788031202
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