Bidur Chandra

Senior Pharmacovigilance Associate @Tata Consultancy Services

Indore, IN

Working as a Senior Pharmacovigilance Associate with the following responsibilities –Processing of serious adverse events (SAE’s) from Clinical (Phase Patient support program and Spontaneous studies receiving Serious Adverse Events of Clinical and Spontaneous studies from global sources in various documents.Performed triage, completeness, legibility and validity of incoming adverse event case reports (Serious and Non-serious events) originated from clinical and post marketing studies.Following a sequential order of assessments like case validity assessment, acceptance of case for processing, triaging of case, case initiation, processing and submission.Case Initiation - Identification of duplicate cases enters basic data into database, create tracking number and acknowledge receipt of case to sender. Must be completed within 24 hours of receipt to ensure tracking of workload and to prevent lost cases.Coordinated with data management, clinical team and investigational sites for SAE queries reconciliation. Transfer data from source documents into database, many types of information to be entered, may send queries on discrepancies to sender.Timelines are tight (drug specific timelines) to ensure as much time as possible for scientific and medical assessment, company uses proprietary system, ARISg and other client owned tools and software’s.AE/SAE management, MedDRA/WHO coding, labelling assessment of AE/SAE, Causality assessment using different scale.Effective identification of SUSAR cases (specific timelines) and processing them by coordinating different functional groups in case processing and submission chain.Effective Safety Narrative writing with medical cohesiveness meeting client specific accuracy level.Efficient coordinating with different functional groups, e.g. team leaders, clinical data verifiers, and other health care professionals and QC’S for completion of various cases with accurate consistency and proper validation.

Bengal School of Technology 193

Master of Pharmaceutical Technology (M.Pharm)

Bengal School of Technology 193

B.Pharm