Dr. Jay Dave Email & Phone Number

Ahmedabad, Gujarat, India

Ahmedabad Area, India

Lead - Global Risk Management Systems and Aggregate Reports• Ensure development and performance of risk management strategies, including effectiveness assessments and Global risk communication.• Lead Risk Minimisation measures tracking and compliance monitoring via metrics• Manage Aggregate Reports (PSUR, PADER, BRER, DSUR) Deliverables • Designing pharmacovigilance processes and procedures within Global PV setup.• Responsible for ensuring appropriate HA response and RFI closureLead- QPPV Oversight group (PSMF & QPPV Support Office)• Lead a team of PSMF Writers and manage PSMF deliverable• Support EUQPPV for enhanced PV Oversight• Local QPPVs Deliverable management• Act as a lead SME for Audit strategy development• Guide Regulatory Recommendations advisory group

Ahmedabad Area, India

• Leading Aggregate Reports & Risk Management System Team• Monitoring the work progress, ensure timely delivery, participating in status meetings, updating project progress to the stakeholders• Train and mentor employees on Aggregate Reports and Risk Management System (RMP/RMS/REMS) writing and relevant pharmacovigilance activities (if required), as per global guidelines• Acts as safety lead for projects; to include set-up, project management, client liaison• Assist Business Development for client development presentations that involve safety reporting as a potential service; provide adequate input into client proposals

London, United Kingdom

As Deputy QPPV- Lambda Therapeutics LTD• EUQPPV Support• Oversee ongoing safety evaluation of MAH’s Authorised products• Collaborates with the applicable global or local PV Quality Assurance (QA) staff to aid the audit planning process. • Contracts and Agreements safety review oversight• Review and assurance of compliance with current procedures.• To identify areas requiring improvement in order to perform-good pharmacovigilance practice.• Oversee design and implementation of training program for pharmacovigilance As Medical reviewer• Medical review of Aggregate Reports, RMPs• Signal Management• Safety AnalysisAs Client Manager • Strategy making with client for anticipated workload/issue resolution• Preparation and Finalization of PMP, SDEA• Review DDPS/PSMF/Regulatory Documents and requests• Training Global Client designates and affiliates regarding PV activities and Local Regulations

Ahmedabad Area, India

As Medical reviewer– Lambda Therapeutics PVT LTD• Medical Assessment of ICSR and Aggregate Reports • Risk Assessment and characterisation documents (RMP, RMS, REMS) Review• Signal Detection• CCSI preparationAdditional ResponsibilityAs Client Manager – Lambda Therapeutics PVT LTD• EUQPPV Support• Strategy making with client for anticipated workload/issue resolutions• Preparation and Finalization of PMP, SDEA• Review DDPS/PSMF/Regulatory Documents and requests• Project management• Training Global Client designates and affiliates regarding PV activities and Local Regulations

Ahmedabad Area, India

As Medical reviewer– Lambda Therapeutics PVT LTD• RMP, RMS Preparation• Medical Assessment of ICSR and Aggregate Reports• Signal DetectionAdditional ResponsibilityAs Client Manager – Lambda Therapeutics PVT LTD• EUQPPV Support• Preparation and Finalization of PMP, SDEA• Review DDPS/PSMF• Project management • Strategy making with client for anticipated workload• Aggregate report assistance• Training Global Client designates and affiliates regarding PV activities and Local Regulations

Ahmedabad Area, India

• Handling of ICSR from triage to submission • Expedited reporting and Regulatory Submission• Literature monitoring (Case reports and published studies)• Safety Database facilitation• Label handling and SPC comparison

I have worked as an associate dentist for a year and have performed all dental surgeries.

M.Sc., Clinical Research

Bds, Dentistry