Dr. Mangesh Nakade PhD sMBA
Angestellt, Sr Drug Safety lead, ICON plc
Mannheim, Deutschland
Über mich
Motivated and enthusiastic Safety physician and Associate Manager with training in international drug safety and pharmacovigilance and safety writing . I had 10 year of experience in total including PV .Able to understand completely the drug safety and related medicinal documentation. Possesses knowledge of different regulations (ICH-GCP, GCP-V, AMG, etc.), pharmacovigilance (GVP, MedDRA, DSUR, PSUR, etc.), clinical data management, quality assurance and control (SOPs, audits and inspections) along with ethics and regulatory authorities submissions. Holds a PhD in veterinary medicine. During PhD and Postdoc studies, worked on different projects mainly focused on pharmacogenetic aspects of side effects of different drugs.(Human and Animal PV specialist). I am also a motivational speaker who is passionate about inspiring the next generation. I am open to serving as an ambassador for multinationals, partnership, ambassadorship, collaboration, promotion, and speech invitation.
Werdegang
Berufserfahrung von Mangesh Nakade PhD sMBA
Drug safety , drug regulatory, clinical research , pharmacovigilance (clinical and post marketing ) -Argus database -Medidata rave -Team handling -AE and SUSAR reporting -1. Timely completion of action items assigned to the PSUR processing team. Based on the information/data provided by GDS, global evaluation and assessment of data for PSUR writing. 2. Medical writing of a succinct summary of all adverse events in the PSUR period, benefit-risk balance of the product in light of any new or changing
a) Case Processor (Local Drug Safety Manager) b) Case Evaluator (Global Drug Safety Manager) c) Managing Global Drug Safety Inbox d) Aggregate report writing (Completed following trainings with example PSUR writing) e)Team Handling Handling time of 30 people of drug safety associate all over the world.
1 Jahr und 5 Monate, Jan. 2019 - Mai 2020
Global Drug Safety Manager in Pharmacovigilance (TCS Budapest)
Bayer-Evaluate adverse event reports, assesses regulatory status based on seriousness and expectedness/relatedness to prioritize the workload. -Quality Review and Case Processing of Initial and Follow- up ICSR’s. -Managed and Coordinated the workflow at different location -Gained Knowledge in ICSR, GVP Modules, ICH GCP and Drug Safety Guidelines for E2b submissions. -Team handling and management -Act as Trainer for new CRE and case processor - Experts in literature cases -Help in internal and client Audit
Ausbildung von Mangesh Nakade PhD sMBA
5 Monate, Jan. 2018 - Mai 2018
Toxicología
University of Veterinary Medicine
2 Jahre und 6 Monate, Aug. 2015 - Jan. 2018
Pharmacology
University of Veterinary Medicine
2 Jahre und 1 Monat, Jan. 2007 - Jan. 2009
Pharmacology
University of Veterinary Medicine
5 Jahre und 1 Monat, Jan. 2002 - Jan. 2007
Veterinary medicine
University of Veterinary Medicine
Sprachen
Englisch
Fließend
Spanisch
Grundlagen
Ungarisch
Grundlagen
Chinesisch
Grundlagen
Hindi
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