Medical Specialist

TCS is Hiring

- Mumbai, Pune

- 2 to 3

- MedDRA, IMDRF and WHODRUG

- MBBS/MD

· Performs medical review of individual case safety reports (ICSRs) including reviewing and assessing device complaints (such as device malfunction and usability problems) reportable and/or non-reportable complaints by reviewing events (including seriousness criteria) and coding with causality, and line listings for investigational and marketed products.

· Makes contributions to process improvement within Patient Safety (PS), particularly with adverse event processing and operational aspects of medical review.

· Ensures meticulous adherence to deadlines. Anticipates events which might impact deadlines and mitigates accordingly.

· Responds to medical review-related questions from other functions in a timely manner.

· When needed, prioritizes work in the interest of timeliness and efficiency.

· Mentors and trains new hires and less experienced colleagues on medical review conventions and tools.

· May perform peer retrospective medical review quality control (MRQC) activities and participate in audits

· Participates in the Gilead biweekly Medical Review team meetings.

· Provides medical input to Strategic Operations on case queries.

· Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements

s.laharika@tcs.com

Regards,

Laharika-TCS HR