Manager – Medical Affairs and Pharmacovigilance

2 months ago

Mumbai, India Unichem Laboratories Limited Full time

Experience - 10 - 12 years


Qualification Requirement - B.Pharm / M. Pharm


Responsibilities


  • Support and execute Pharmacovigilance related activities in UNICHEM Laboratories Limited.
  • Prepare and maintain Pharmacovigilance documentation and SOPs and training to the relevant stake holders
  • Train Pharmacovigilance team on standard operating procedure (SOP) and Work Instruction
  • Train Pharmacovigilance team for conducting Pharmacovigilance training and related programs
  • Organize Pharmacovigilance training to corporate office, manufacturing plants, distributors, and other vendors if applicable in timely manner for new as well as existing UNICEM employees
  • Assist the Pharmacovigilance team to execute all Pharmacovigilance related activities
  • Prepare the periodic safety update reports (PSURs) and submit to the regulatory authorities and risk management plans (RMPs) contribute to Pharmacovigilance matrix to ensure that the Pharmacovigilance system is running in compliance with procedure and requirements
  • Co-ordinate with business partners for preparation and update of SDEA agreements. Prepare and review Pharmacovigilance related documents such as PSURs, PBRER, RMPs, PADER, SmPC, package insert and submission to regulatory agencies
  • Provide the satisfactory response to all medical information and Pharmacovigilance related queries.
  • Communicate with vendors in case of discrepancies.
  • Train QPPV on SOPs and pharmacovigilance.
  • Submit individual case safety reports to regulatory authorities.
  • Support the Medical Affairs team to respond to enquiries from Pharmacovigilance source.
  • Timely submission of PADERs and process invoices in SAP system for payment release.
  • Support in the selection, audit, oversight and conduct regular meetings with service providers (vendors and CROs) for Pharmacovigilance activities.
  • Ensure that all Pharmacovigilance activities are conducted in accordance with UNICHEM SOPs and regulatory requirements.


Desired Skills and Competencies

  • Good Pharmacovigilance knowledge
  • Database Management, Presentation Skills
  • Excellent Communication (Oral + Written)
  • Passionate & Energetic
  • Analytical & Operational
  • Computing Good with technology
  • Team work, Team player

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