Industry - Pharma / Biotech / Clinical Research

Category - Operations

Skills - "Pharmacovigilance", "PV", "ICSR", "PSUR"

Job Type - Permanent

Job Description - Job Responsibilities:

1. 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.

3. 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.

4. Prepare for internal or external/regulatory audits and inspections.

5. Coordinate and conduct annual trainings for Piramal employees and non-technical staff.

6. Support EU QPPV in appointment and coordination with local QPPV in various EU countries as per applicable regulations.

7. Provide data to senior management for oversight on the day-to-day activities and compliance.

8. Ensuring compliance with all the company SOPs, procedures and local privacy related regulations.

9. 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.

10. Coordination with different stakeholders for data request etc. for fulfilment of PV responsibilities like regulatory affairs, medical affairs, sales team, supply chain etc.

12. Keep an oversight on the activities performed by vendors.

13. Management of team including pharmacovigilance executives involved in pharmacovigilance related activities.