Piramal Group Hiring Manager – Pharmacovigilance

Piramal Group Hiring Manager – Pharmacovigilance

27 May, 2022

Job Responsibilities:

  • End to management of case processing workflow including but not limited to ICSR allocation, prioritization of cases that need to be reported to regulatory authorities and business partners.
  • Daily deliverable tracking and provide SME support to the team in pharmacovigilance related activities like signal management, aggregate reports, PSMF maintenance,
  • End to end management of Safety Data Exchange Agreements with Business partners/ Distributors globally including but not limited to drafting SDEAs, periodic reconciliation and support in oversight of business partner activities.
  • Prepare for internal or external/regulatory audits and inspections.
  • Coordinate and conduct annual trainings for Piramal employees and non-technical staff.
  • Support EU QPPV in appointment and coordination with local QPPV in various EU countries as per applicable regulations.
  • Provide data to senior management for oversight on the day-to-day activities and compliance.
  • Ensuring compliance with all the company SOPs, procedures and local privacy related regulations.
  • Maintain awareness of changes to/new regulations affecting pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes.
  • Coordination with different stakeholders for data request etc. for fulfilment of PV responsibilities like regulatory affairs, medical affairs, sales team, supply chain etc.
  • Provide support in distributor risk assessment and distributor audits.
  • Keep an oversight on the activities performed by vendors.
  • Management of team including pharmacovigilance executives involved in pharmacovigilance related activities.

Qualifications

Qualifications

B pharm, M Pharm

Experience

Working in pharmacovigilance for atleast 8 years including team managment

Primary Location:

India-Maharashtra-Mumbai

Apply through this Link

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