Venkatraman Balasubramanian
Physician @Parexel
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WORK HISTORY
Physician @Parexel
Hyderabad, IN
As a Global Safety Officer, Dr Venkatraman Balasubramanian expertise for assigned products, maintains PV expertise, and understanding of international safety regulations and guidelines. Provides and maintains PV and risk management expertise to internal and external customers. Maintains knowledge of product, their environment and recent literature. Communicates and represents PV data evaluation, interpretation and summary or conclusions as relevant. Responsible for signal detection and analysis. as well as review, preparation, and/or contribution to responses to questions from health authorities, ethics committees, Internal Review Boards (IRBs), external partners. Manages product safety alerts, as needed. Responsible for Identifying and implementing proactive safety analysis strategies to further define the safety profile of the product. Provides proactive risk assessment. Responsible for documenting, coordinating, reviewing and validating periodic reports, e.g: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report, Health Hazard Evaluation etc, Leads the preparation of clinical overview to support labelling changes and oversees the safety part of the Company Core Safety Information (CCSI) creation.\\\\n15 years of experience working in drug safety and pharmacovigilance domain comprising adequate expo-sure in literature surveillance and monitoring for signal related activity, Individual Case Safety Report (ICSR) medical review (more than cases), medical data review, post box cases, Clinical trial SAE review and AOSE drafting, Medical safety surveillance/signal detection benefit/risk assessment and development of trend analyses and medical review and interpretation for aggregate safety reports.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
EDUCATION
Ghent University
Master, Molecular Biotechnology
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MBBS, Bachelor of Medicine & Bachelor of Surgery
Christian Medical College, Vellore
Post Graduate Diploma, Family Medicine
ABOUT VENKATRAMAN BALASUBRAMANIAN
Venkatraman Balasubramanian is a Physician by training and has wide experience in pharmcovigilance safety review process. After completing medical school, I practised in the field of Oncology and Cardiology for more than 3 years in a tertiary care hospital. I also have Masters in Medical Biotechnology (Ghent University, Belgium). I worked as Medical Review Safety Physician in a multinational PVG service provider for a leading Global Pharma from 2008 to 2009. I was a critical resource for medical assessment of Individual Case Safety Report (ICSR) in various therapeutic areas including Cardiovascular and Oncology. I was involved in assessment of SAE in global clinical trials involving Cardiology and Oncology drugs. I was with PAREXEL since May 2009 till August 2011 as Senior Drug Safety Physician. I served as lead Physician in various projects involving ICSR medical review, CCDS update, PSUR medical review, literature search review, signal detection, Medical Monitoring and narrative writing for leading global Pharmaceuticals across various therapeutic areas. Have worked on various safety data bases ( CARES, ARGUS, ARISG, SCEPTRE and Clintrace) Presently I am with Quintiles as Manager Pharmcovigilance Physician. Specialties: Pharmacovigilance, Drug safety, Medicine, Biotechnology
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