As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
The Senior Consultant, Pharmacovigilance provides leadership for and performs key functions within the Elanco Animal Health Global Pharmacovigilance Unit and the North American affiliates. The incumbent is the Local PV Manager (LPVM) for CA and serves as the primary company point of contact on Pharmacovigilance matters in the affiliate for external and internal customers. The position holder may be involved in and responsible or accountable for further pharmacovigilance activities and projects as assigned, such as participation in the Global Safety Council meetings.
Functions, Duties, Tasks:
Responsible for establishing and maintaining the local pharmacovigilance system and compliance with local regulatory and Elanco requirements (e.g., reporting of Adverse Events (AE) and Product Complaints (PC).
Manage communication with the NCA on topics related to the safety of Elanco products to ensure a timely response and clarity of message, collaborating with GPV and Regulatory Affairs as required. Develop and maintain the relationship with the NCA related to PV; act as the lead point of contact for NCAs concerning PV in the region/affiliate.
Ensure delivery of appropriate PV training to Affiliate / Hub employees (including third parties with contractual arrangements for PV) on the local procedures for AE/PC reporting and other relevant PV topics.
Monitor changes to local PV regulations, and ensure timely communication of this, and any other relevant safety-related communication raised by an NCA, to the GPV Team.
Work with Product Safety Management and Data Processing Management Teams to ensure completion of the required tasks according to local regulatory and Elanco requirements.
Where there is local responsibility for the submission of AE reports / reportable events to Competent Authorities, then the LPVM/LPVR ensures that:
these submissions are adequately documented and archived
GPV receives immediate notification of any potential late submissions, and
a monthly compliance report is submitted to GPV. These processes should be documented in the Local Pharmacovigilance SOP
Act as the local point of contact for third parties with whom Elanco has PV Agreements (PVAs). With GPV and Quality, ensure PVAs contain appropriate wording and support compliance with terms of agreements (e.g., provision of training, reconciliation of cases, etc.).
Facilitate PV audits and inspections in the Affiliate / Hub, in conjunction with GPV and Quality, and ensure execution of any corrective action plans.
Work with GPV to coordinate and promote Elanco’s interests in local Industry Associations (e.g., PV working groups).
Collaborate with the EU QPPV and GPV colleagues as required to support the implementation and maintenance of the GPV system to ensure product safety at a global level.
Basic Qualification:
Veterinary, medical degree or PhD in a scientific field applicable to animal health and pharmacovigilance is required
A minimum 2 years’ experience in pharmacovigilance. Additional experience in Regulatory Affairs and/or Quality and in interaction with regulatory health authorities is preferred
Awareness of internal and external stakeholders and regulatory, political and legislative environment and influential partners within the affiliate
Other Information:
Minimal Domestic & International Travel
Language requirements: English at minimum, French beneficial
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
