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

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