Hansmukh Jain
Medical Quality Governance Manager at Pfizer
- Role
- Medical Affairs Manager at 화이자
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Hansmukh Jain
Responsible for providing support to the Pfizer Biopharmaceuticals Group (PBG) Hospital Business Unit (BU) Global Medical Affairs team specifically.
Experience
Medical Affairs Manager
Jan 2021 — Present
Performs medical pre-review (reference check) of promotional, sales training and medical to medical materials, including but not limited to, Health Care Professional (HCP) promotional aids, Web/Social, training material, advertisements, consumer promotions, conventions/ meetings to ensure:The claims are accurate, truthful, not misleading and aligned with Core Claims, Common Technical and/or other regulatory documents.Providing support to the Global Medical Affairs group, including but not limited to ad-hoc literature searches, reviews and summaries, preparation of slide decks. • Researching literature databases, internal and external repositories to support the evaluation of Health Hazard Assessments and the benefit-risk of Pfizer products.• Support for major regulatory agency submissions, Clinical Overviews, Health Hazard Assessments, listings and summarizing the results of the above research to the required standard.• Supervision and review of the Global Medical Product Evaluation (GMPE), promotional material and publications work performed by the associates, in order to provide high quality and timely service.The Medical Manager supports and partners with GMPE Therapeutic Area (TA) Leads and Global Medical Affairs by:• Creating documents pertaining to clinical data, company data, published literature and other data to support the maintenance and defense of our products. Some examples of such document include briefing documents to support meetings with regulatory agencies, clinical overviews and clinical efficacy section in support of Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Periodic Safety Update Reports (PSURs), Addendum Reports, Health Hazard Assessments (HHAs), critical review and analysis of the medical literature and responses to clinical and safety questions from regulatory authorities.
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