Senior Manager Dsrm (medical Reviewer)

Lupin Ltd

Airoli, MH, India
On-site
Medical review of health hazard assessment
Signal detection and evaluation activities
Aggregate reports
Oversight and management of Medical Review and Signal Management related activities

Job Summary

  • Oversight and management of Medical Review and Signal Management related activities.
  • Review of relevant literature articles for aggregate reports and signal activities.
  • Supporting team in preparing device malfunction report and drafting response for Health Authority request.

Matching Summary

Oversight and management of Medical Review and Signal Management related activities.

Skills & Requirements

Must-have

  • Medical Review of Health Hazard Assessment
  • Signal detection and evaluation activities
  • Aggregate reports
  • Individual Case Safety Reports
  • Pharmacovigilance documents review
  • Device malfunction report preparation

Nice-to-have

  • Innovation & Creativity
  • Result Orientation
  • Developing Talent
  • Process Excellence
  • Collaboration
  • Stakeholder Management

Key Requirements

  • 5 to 10 years of Pharmacovigilance experience
  • Expertise in aggregate report
  • Expertise in signal detection
  • Expertise in clinical safety/SAE management
  • Doctorate
  • Graduation in Medicine

Work Rights

Not specified

Tailored Resume

Cover Letter