Regulatory and Pharmacovigilance Specialist
Elanco
📍 İstanbul, İstanbul, Turkey
Job Description
Responsibilities:
A member of Turkey Regulatory and PV team and work closely with global Elanco PV organization.
Pharmacovigilance:
Act as Qualified Person for Pharmacovigilance (QPPV) for Turkey and perform all the QPPV related tasks for Elanco Turkey affiliate.
Act as point of contact and provide visible leadership for all PV matters in Turkey.
Ensure the local Regulatory Authority (RA) are informed of AE cases according to local regulatory and Elanco requirements, following the required process.
Monitor changes to local PV regulations, and ensure timely communication of this, and any other relevant safety related communication raised by the RA to the Elanco PV Team.
Responsible for compilation of PV Metrics and Safety Monitoring activities for locally registered products.
Regulatory Affairs:
Accountable for providing accurate and up t...