Pharmacovigilance Scientist - Pune, India - Fusion Technology Solutions

Fusion Technology Solutions
Fusion Technology Solutions
Verified Company
Pune, India

1 week ago

Deepika Kaur

Posted by:

Deepika Kaur

beBee Recuiter
Description
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, Fresher


Salary:
₹15, ₹30,799.62 per month


Benefits:


  • Commuter assistance
  • Flexible schedule
  • Provident Fund

Schedule:

  • Day shift
  • Fixed shift

Supplemental pay types:

  • Performance bonus
  • Yearly bonus
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