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Sharad Patel

Sharad Patel

Manager Global Pharmacovigilance

Healthcare

Mumbai, Maharashtra

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About Sharad Patel:

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

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