Pharmacovigilance Associate

6 months ago


Pune, India Statistical Pharma Full time

**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**: ₹287,279.93 - ₹1,252,862.82 per year

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Provident Fund
- Work from home

Schedule:

- Day shift
- Morning shift
- Rotational shift

Supplemental pay types:

- Performance bonus
- Yearly bonus

Work Location: In person



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