Pharmacovigilance Scientist

1 month ago

Pune, India Fusion Technology Solutions Full time

Position Responsibilities General Product Support

Supports Medical Safety Assessment Physician (MSAP) leading signal detection activities for a product's emerging safety profile.

Prepare/write PV sections of aggregate safety documents (eg, DSUR, PBRER) and analyze data for the RSI section of the IB. Write and analyze data for ad hoc responses to health authorities, with oversight.

Execute strategy for signal evaluation (eg, case-series, literature review, HA/ claims database). Document signal by Safety Topic Review/ Signal Report.

Analyze data and prepare documentation to support label updates for assigned products, with oversight.

Support Safety input for regulatory product labeling.

Support the EU QPPV or other regional or local Qualified Person for safety issues relating to assigned products.

Working knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities. Share with individuals and teams on these applied learnings.

**Job Types**: Full-time, Permanent, Fresher

**Salary**: ₹24,000.00 - ₹72,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund
- Work from home

Schedule:

- Day shift
- Morning shift
- Rotational shift

Supplemental pay types:

- Commission pay
- Performance bonus
- Yearly bonus

**Speak with the employer**
+91 8788031202

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