Mandar Kelkar

Safety and Risk Management Lead @argenx

Swindon, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2025 — Present

Safety and Risk Management Lead @argenx

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Ghent, BE

EDUCATION

2002 — 2004

Institute Of Chemical Technology

M.Pharm, Medicinal Natural Products

2004 — 2005

Tata Cancer Research Memorial Institute

Junior Research Fellow, Chemoprevention

1998 — 2002

University of Mumbai

B.Pharm, Pharmaceutical Sciences

SKILLS

Medical WritingU.s. Food and Drug Administration (Fda)Safety Management SystemsClinical DevelopmentQuality SystemIch-GcpRisk ManagementPharmaceuticsBiotechnologyClinical TrialsMarket ResearchPharmaceutical IndustrySopFdaDrug SafetyCrf DesignStrategyQuality AssuranceCRO ManagementPharmacovigilanceRegulatory AffairsLifesciencesGood Clinical Practice (Gcp)Life SciencesValidationRegulatory SubmissionsCROStandard Operating Procedure (Sop)TrainingGcpProject ManagementArgus Safety

ABOUT MANDAR KELKAR

Mandar is internationally experienced, Pharmacovigilance Leader, with significant experience in establishing full scale Pharmacovigilance to cover global operations and business development activities.Commercially aware and results orientated with rich experience in staff development and motivational skills, he is recognised for being customer focused, with excellent relationship management skills.He has diverse experience of working in various types of business models like pharmaceutical companies, Start-ups, Business Process Operations, Contract Research and Knowledge Processing Organisations. He is one of the key participants in developing customised PV solutions for prospective clients, responses to RFPs, bid defense, and due diligence activities. This has resulted in significant business development- expansion of existing and new scope of activities, and logos.In addition, Mandar was a visiting faculty lecturer teaching pharmacovigilance for a couple of institutions affiliated to University of Mumbai. Areas of experience include: • Global Pharmacovigilence• Drug Development Project Management• PV System and Tools Design and Implementation• Staff recruitment, Training and Appraisal Management • Business Solutions Consulting• Transition Management• Due Diligence Activities

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Mandar Kelkar — Safety and Risk Management Lead at argenx in Swindon, GB | Unifers