Sumit Gunjal

Process Associate @Tata Consultancy Services

Mumbai, IN

Review, assess, and prioritize Individual Case Safety Reports (ICSRs) ensuring timely and accurate processing.2. Validate case data for completeness, accuracy, and regulatory compliance while maintaining data integrity.3. Determine seriousness, expectedness, and reportability of cases according to global regulations and product labeling.4. Enter and maintain safety data in LSMV databases with precision and adherence to SOPs.5. Draft clear case narratives and initiate follow-up actions to resolve missing or clarifying information.6. Collaborate with global safety teams, local affiliates, and clinical teams for data reconciliation and compliance.7. Support audit readiness by maintaining organized documentation and participating in inspections.