Dr. Amit Jadhav
Director Global Patient Safety, CVS and metabolic at Regeneron- Claim this Profile
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Bio
Experience
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Regeneron
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United States
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Biotechnology
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700 & Above Employee
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Director Global Patient Safety, CVS and metabolic
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Jan 2023 - Present
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UCB
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Belgium
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Pharmaceutical Manufacturing
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700 & Above Employee
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Jun 2020 - Feb 2023
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Apr 2019 - May 2020
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Mundipharma
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Pharmaceutical Manufacturing
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700 & Above Employee
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Drug Safety Physician
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Mar 2014 - Mar 2019
- Experience in wide TA's such as Pain, addiction and Oncology - Ongoing Clinical development: Active input in Phase I /III trials, Scientific advice meetings (NCA, PRAC rapporteurs, EMA), internal Data monitoring committee, MA Submissions and successful MAAs. - Proactive input in successful implementation of Risk Minimisation measures (RMMs) for the local associate companies. - Safety surveillance. Author and review aggregate and safety reports ( DSUR, PSUR, CCSI) - Scientific input, oversight and management of Post Authorisation studies (PASS, PAES) - Due diligence, Alliance Management, Strategic input for process alignment, Medical review of ICSRs. - Active member of Signal Evaluation Group to provide clinical and PV expertise, - Labelling support - Working cross-functionally in a matrix environment Show less
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Pfizer
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Medical Advisor
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Nov 2011 - Jan 2014
Medical Affairs: Medical Advisor in Specialty Division handling Ophthalmology and Endocrinology therapeutic areas. Medical assessor for the product planning, in licensing and Acquisition of products in Pfizer India Actively contributed to the organization by taking responsibility for the scientific and ethical soundness of all endeavors. Worked closely with Pharmacovigilance and Regulatory team on a continuous basis. Provided scientific support to the clinicians in research activities, provide high quality and timely service in the areas of Product Commercialization/Promotional support, New product launch, Interactions with Healthcare Professionals, Advisory Board meetings, Expert Group meetings, International Speaker Programs, CMEs, Clinical Research, Sales Force Training, Medical Informationand business support in the areas of New Product Development and Business Technology Show less
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M.D.
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Feb 2008 - Jun 2011
Participated in National level quiz competition in National conference in AIIMS, Worked as a Co-ordinator in Clinical Trial in Cardiology Department. Two abstracts published in Indian Journal of Pharmacolgy (indexed journal in pubmed) Poster presentation in National conference. Original article published Participated in National level quiz competition in National conference in AIIMS, Worked as a Co-ordinator in Clinical Trial in Cardiology Department. Two abstracts published in Indian Journal of Pharmacolgy (indexed journal in pubmed) Poster presentation in National conference. Original article published
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M.B.B.S.
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2000 - 2006
Medical graduation, Internship Medical graduation, Internship
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Education
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Faculty of Pharmaceutical Medicine UK
Diploma in Pharmaceutical Medicine -
Baxter Boydes Course
Pharmaceutical Medicine -
Topiwala National Medical College, MUHS
Doctor of Medicine (MD), Pharmacology -
Welingkar's Institute
Post Graduate Diploma in Marketing Management (PGDMM), Marketing -
St. Augustine
Secondary school certification