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Pharmacovigilance Auditor 1 Professional Summary

  • MBBS and Post Graduate (MD) in Pharmacology, he is highlyexperienced Professional having demonstrated the ability to lead diverse activities of Pharmacovigilance and Clinical Research, to new levels of success and exceeding business goals, inahighly competitive, cutting-edge,andfast-pacedenvironment.

  • He has faced conducted and faced global audits and inspections by leading regulatory agencies. He has deep understanding of case processing, medical review, signal management and risk management.

  • Experienced in managing global cultural diversity; as a skilled change leader,with excellent communication and interpersonal skills, consistently developing higher performing Global Pharmacovigilance and Clinical research teams. Strong Technical qualifications with an impressive Commercial acumenin recognizing opportunities and making right decisions.

  • Nineteen plus(19+) years of hands-onexperience in strategic planning, attainment of quality and financial standards, budget preparation, and overall coordination of Global Pharmacovigilance and Clinical Research operations.

  • Implemented, Validatedand Established global safety databases like ARGUS, ARISg for Multiple Global Pharmaorganizations. Developed from scratch, an E2B compliant end to end safety databases like PvNET and IPS(Proprietary safety database of TCS).

  • He has worked with several global organisations on senior pharmacovigilance positions, including Global Pharmacovigilance Head, Cognizant Technologies; Vice President Lambda Therapeutics; Group Leader – Pharmacovigilance, Ranbaxy; Head Global Pharmacovigilance at Aurobindo and Panacea. Currently working with several global organisation as senior pharmacovigilance consultant / auditor.

  • For System Demo and further information, please call +91 98100 68241 or mail us at bd@crqa.in