Sharad Patel
Manager Global Pharmacovigilance
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About
Clinical Research professional with 14 plus years of experience in core Pharmacovigilance.
Experience on working on vendor side, CRO and currently handling Global PV team at India site for Glenmark PV.
Global Intake to Submission'
Vendor Management for PV and IT
Safety Data Exchange Agreements Team for Glenmark
Stakeholder collaboration with Global Medical Affairs, Regulatory Affairs, Product Quality complaint's
IT automation and configurations for Safety Database and CRM for Global Case Intake
Audits and Inspection of Affiliates, Licensee Partners and Health Authorities
Represented Health Canada, BFarm, USFDA and MHRA inspections for Glenmark
People Management, Resource utilization, capacity planning within approved budget
Monitoring compliance and quality KPIs for vendors to ensure regulatory compliance for PV is maintained.
Experience
14 plus years of core experience in ICSR case processing
Variety of experience in Client management and Vendor management
Education
PG Diploma in Clinical Research
