
Vishal Shinde
Pharmacovigilance : •Responsible and accountable for all aspects related to the handling of safety information originating from post-marketing, clinical... | Mumbai, Maharashtra, India
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Vishal Shinde’s Location Mumbai, Maharashtra, India
Vishal Shinde’s Expertise Pharmacovigilance : •Responsible and accountable for all aspects related to the handling of safety information originating from post-marketing, clinical trials, literature, and other sources. •Investigation, documentation, medical research, and processing of incoming Adverse Drug Events (ADEs) or Reactions (ADRs) as per SOPs. •Reviews cases for expectedness and seriousness. •Maintains in-depth knowledge of the assigned projects, regulatory requirements, and other safety-related initiatives. •Supports the team on safety-related issues. •Contributes to regulatory responses, IBs, study protocols, CRFs, Reports, and other documents as required. •Retrieves information from the safety database for use in aggregate safety reports for dissemination to PV and to fulfill regulatory compliance. •Works as an effective team member in Global PV Group •Collaborates with GPV Group on effective processes with 3rd parties for any outsourced activities A Research Professional in Clinical Research with research experience of around 6.5 years in Clinical Research. •Conducting clinical trials in Phase I, II ,III & IV. Experienced in Investigator initiated projects/ clinical trials/ multicentric trials. •Designing of Protocols, screening volunteers and subject enrollment for study, ICF, SD, CRF etc. •Coordination with Study staff, Investigators, Collaborator, Ethics Committee, Sponsor and CRO. •Organized the ICMR workshops, conferences and courses in Clinical Trials & Clinical Research.Worked as Research Associate on various Pharmacogenomics projects like •Pharmacogenetics of Adverse Drug Reactions of anticoagulant, antiplatelet, immunosuppressant and antiepileptic drugs. •Standardizing ABCB1, CYP3A4, CYP3A5 genes by PCR RFLP method. •Worked on estimation of antiepileptic drugs by High Performance Liquid Chromatography for the patients referred to Therapeutic Drug Monitoring (TDM) OPD
Vishal Shinde’s Current Industry Bristol Myers Squibb
Vishal
Shinde’s Prior Industry
Department Of Clinical Pharmacology
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Bristol Myers Squibb
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Work Experience

Bristol Myers Squibb
Head of Country, Pharmacovigilance
Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Bristol Myers Squibb
Project Associate
Sat Jun 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Department Of Clinical Pharmacology
Clinical Research Associate
Tue Nov 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue May 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)