Vismay Sawant

Pharmacovigilance Associate @Cognizant

Mumbai, IN

Case processor: Novartis pharmaceuticals project\\\\n- Processing ICSRs (individual case safety report) of oncology drugs of Novartis pharmaceuticals into Argus database.\\\\n- Triages ICSR and analyze ICSR data for completeness and prioritize cases by seriousness and regulatory timeline.\\\\n- Evaluate and analyze drug criteria for validity of suspect drugs using an IPL (integrated product list)- Duplicate search and book in of cases.\\\\n- Coding for AEs (adverse events) and manual coding of codeable terms which did not get auto encode using MedDRA.\\\\n- Coding of medical history, lab data by MedDRA and co-suspect, concomitant and treatment medications by WHO-DD.\\\\n- Assessment of seriousness, labeling and causality of events with the help of CDS, USPI and RSI documents.\\\\n- Safety narrative writing: Editing and writing grammatically correct narrative in right chronology with summarization of essential details of the case.\\\\n- Recognizing information to be queried and follow up until information is obtained and queries are resolved.\\\\n- Cross verifying NTBD cases (not to be databased cases) and provide approval to reject invalid cases to associates.\\\\n\\\\nTrainer/ Mentor:\\\\n- Training and mentoring new team members on case processing guidelines.\\\\n- Creating and delivering presentations of IPL (integrated product list) and new conventions of Novartis case processing on weekly basis.\\\\n\\\\nCCF/ Correction reviewer:\\\\n- Reviewing corrections made in the cases and filled CCF (case correction form) and giving approval for locking cases to other case processors.\\\\n- Maintaining correction tracker and evaluating correction data.\\\\n- Lead operation performance management reporting and presentation to the leadership team.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n

Sathaye College - India

Master's degree