- 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.
B pharm, M Pharm
Working in pharmacovigilance for atleast 8 years including team managment
Apply through this Link