Mayank Sharma, M.Pharm, RPh

Experience

• 

  Cipla

  Sept 2008 - Apr 2009

  Production Officer
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  WIPRO HLS

  Dec 2011 - Jun 2014

  Book-In, Whole Case processing: Narrative writing, Event Assessment, Seriousness criteria, Listedness and conducting all the required follow-up activities.Experienced in Adverse Events coding (MedDRA 16.0) and Drug coding (WHO DD and CDD)Expertise in ARGUS Tabs and handling cases from various sources

  • Quality Analyst

    Dec 2013 - Jun 2014

  • Pharmacovigilance officer

    Dec 2011 - Dec 2013
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  YES Regulatory Healthcare Services - a member of PharmaLex GmBH

  Jun 2014 - Mar 2016

  Jr. Medical Advisor

  Pharmacovigilance (processing/medical review of ICSRs and other adverse event reports; generating follow-up requests specially with physicians, preparing aggregate reports PSURs, RMPs ensuring compliance with regulatory and company requirements)• ARGUS, VONE Data Base, MedDRA, training on “Managing Self and Others”.• Writing and Review of Safety narrative• Writing and Review of PSURs/Aggregate reports• Writing and Review of Pharmacovigilance Control documents.• Processing and Quality Review of ICSRs Show less

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  PharmaLex India

  Apr 2016 - Mar 2021

  Manager-Pharmacovigilance

  • Monitor Compliance adherence and ensure a monthly review of status.• Ensure Risk assessment is conducted for the process at the start of Operations and on any major change taking place.• To impart pharmacovigilance training to team members and other departments related to PV procedures and regulatory obligations.• Responsible for effective compliance of all PV system and outsourcing model.• Strong leadership for driving excellence along with Analytical & numerical skills.• Decision making & problem-solving attitude with good insight on numbers. Show less

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  Cencora PharmaLex

  Apr 2021 - now

  Senior Manager-Pharmacovigilance