Sampada Deshpande
Drug Safety Professional | 4+ Years in Pharmacovigilance | Expertise in ICSR Processing (Legal, Literature, Medicinal & Non-Medicinal) & Quality Review | Skilled in Argus, ARISg | PV Operations
- Role
- Safety Science Coordinator-i at Fortrea
- Location
- Navi Mumbai, MH, IN
- LinkedIn followers
- 500 followers
Experience
Safety Science Coordinator-i
Jun 2023 — Present · Mumbai, IN
Proficient in using safety databases such as ARISg and Argus, with a deep understanding of workflow, data entry, coding, and narrative documentation.Spearheaded the quality review process for spontaneous, legal, and literature ICSRs, ensuring high data accuracy and compliance.Possess strong experience in processing both serious and non-serious Individual Case Safety Reports (ICSRs), including those involving medicinal and non-medicinal products.Well-versed in handling MoCRA (Modernization of Cosmetics Regulation Act) cases, specifically related to cosmetic product safety reporting within the USA.Played the role of Subject Matter Expert (SME) in the intake process, guiding teams on case validity assessment, seriousness criteria, and follow-up requirements.Provided training and ongoing mentorship to junior team members, enhancing team capability and overall case processing efficiency.Conducted follow-up on safety-related queries to ensure timely and complete case information.Achieved a 95% reduction in adverse event reporting errors through continuous process improvement and rigorous quality checks.Addressed and coordinated safety-related inquiries from multiple stakeholders, including internal teams and external partners.
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