Sharad Patel
Manager, Global Pharmacovigilance I PV Agreements I Vendor Manager I ICSR I Global Case Intake Call Center I Project Management I Literature I Medical Information Enquiries I Aggregate Reports I Regulatory Intelligence
- Role
- Manager, Pharmacovigilance Case Processing i Pv Agreements i Pv Vendor Management at Glenmark Pharmaceuticals
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Sharad Patel
End to end Pharmacovigilance Project management PV AgreementsAffiliate Management Resource EstimationClient handlingCapacity Planning Tracking and Delivering efficient KPI\'s and SLA\'s, Conducting interviewsPharmacovigilance TrainingExecuting Quality InitiativesStakeholder ManagementConducting Pharmacovigilance seminarsDelivering Clinical Research with high profitability Major Activities :1. Manage end to end global Pharmacovigilance operations of ICSR Case processing and intake call centre for AE PQC MI.2. PV/SDEA Agreements: Lifecycle management of PV Agreements ( Initiation, Review, Draft, Finalisation)3. Affiliate Management:Liaise with local PV personnel to fulfill the local regulatory requirements for approved products, social media monitoring, reconciliation and regulatory intelligence updates.4. SERM Activities Review of US Aggregate reports, PADERs, SAR, SER as inhouse activity 5.Global Literature Monitoring EMBASE6. Medical Information Receive and resolve MI enquiries for APAC Region7. Product Quality CompliantCompliance to circulating PQCs to MFR site, IR reports, Field Alert Report.8. People Management Recruitment, Training, Appraisal of Tea members 9. Vendor Management Liaise with PV vendor to ensure appropriate support from sponsor is leovided to deliver the PV ICSR activities.Oversight on Quality & Compliance of vendor outsourced activities Review of Billing for vendor activities 10. IT CSV Activities Lead and support new product configuration, study configuration, change control in SAP,Participate in IQ OQ PQ drafting, review and approval process.11. Procedural Document QMSDraft review and approve the procedural documents, work instructions and associated documents for PV project.8.
Experience
Manager, Pharmacovigilance Case Processing i Pv Agreements i Pv Vendor Management
Oct 2020 — Present · Mumbai, IN
Education
Maharashtra University of Health Sciences
BHMS
2002 — 2007
PG Diploma in Clinical Research (Pharmacovigilance)
Pharmacovigilance
2009 — 2010
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.