• Job Description

  Req#: R0014009

  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.

  Position Description:

  This role acts as the TMEA PV Manager for the Elanco PV organization, and is responsible for, and provides leadership, on all PV issues and actions in the holder’s TMEA region, including any local legal obligation for the provision of a Pharmacovigilance contact person to a Regulatory Authority (RA). The role will be a member of the Regional Pharmacovigilance Team and will collaborate globally as required to ensure delivery of wider Elanco PV responsibilities.

  At the local level, the role ensures the compliance of the TMEA region Pharmacovigilance system with local regulatory and Elanco requirements. This includes, but is not limited to, the collection and submission of AE reports, PSURs, development of relevant SOPs etc. The role requires the holder to build a strong network across the TMEA region to enhance value for both internal (e.g., commercial and regulatory teams) and external customers (including Regulatory Authorities).

  The role will also act as Qualified Person for Pharmacovigilance (QPPV) for Turkey and perform all the QPPV related tasks for Elanco Turkey affiliate.

  In addition, the role will also perform regulatory affairs duties (40% workshare) for TMEA region. The role will have a dotted reporting line to Head of Regulatory Affairs TMEA region.

  Functions, Duties, Task:

  TMEA PV:

  • 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 for, and provide visible leadership, for all PV matters in their TMEA region.
  • Responsible for establishing and maintaining the local pharmacovigilance system (including any necessary local SOPs) and monitoring its performance to ensure compliance with local regulatory and Elanco requirements (e.g., reporting of Adverse Events (AE) and Product Complaints (PC)). Maintains awareness of PV cases in the TMEA region.
  • Ensure the local Regulatory Authority (RA) are informed of AE cases according to local regulatory and Elanco requirements, following the required process.
  • Manage communication with the local RA on topics related to the safety of Elanco products to ensure a timely response and clarity of message, collaborating with Elanco PV and Regulatory Affairs as required. Develop and maintain the relationship with the local RA related to PV; act as the lead point of contact for RAs with regard to PV in the TMEA region.

  • Ensure delivery of appropriate PV trainings to TMEA region 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 a RA, to the Elanco PV Team.
  • Where there is local responsibility for the identification / tracking / preparation / submission of periodic safety monitoring reports, 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 required, ensure local literature review is performed in line with local regulatory and Elanco requirements.
  • Work with Elanco PV to facilitate review of local research and post marketing studies protocols to ensure compliance with PV reporting requirements.
  • Act as local point of contact for third-parties with whom Elanco has PV Agreements (PVAs). With Elanco PV 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 TMEA region, in conjunction with Elanco PV and Quality, and ensure execution of any corrective action plans. Proactively maintain TMEA region in an audit and inspection ready state.
  • Work with Elanco PV to co-ordinate and promote Elanco’s interests in local Industry Associations (e.g., PV working groups).
  • Proactively identify, suggest and lead strategic improvement initiatives to support product safety, drive efficiency and compliance, and deliver value.

  GLOBAL PV:

  • Collaborate with the QPPV and PV colleagues as required to support the implementation and maintenance of the Elanco PV system to ensure product safety at a global level. Areas of collaboration may include:
  • The review, analysis and interpretation of PV data to identify potential safety trends and signals in order to make recommendations for risk mitigation/management – e.g., support for Product Stewardship activities, preparation of aggregate reports, requests from other business partners.
  • Participation in global safety governance meetings when required.

  TMEA Regulatory Affairs:

  • Support the preparation and/or review of documents for submission to regulatory authorities.
  • Ensures compliance to procedures and systems necessary to maintain proper records.
  • Work with local distributors to compile and follow registration submissions with respect to relevant regulatory authority regulations and policies.
  • Contributes to ensure regulatory compliance to product labels.
  • Responsible & accountable to fulfill the role in the creation, review and approval of Promotional Materials as defined in current valid Elanco Global Quality Standards (EGQS) and/or Elanco Functional procedure (Elanco Functional Procedures) on Promotional Materials
  • Performs other related duties and assignment as required by the regulatory affairs lead

  Minimum Qualification (education, experience and/or training, required certifications):

  • Pharmaceutical / life-science orientated studies (e.g. – veterinary / human medicine, pharmacy, biologist, biochemistry) or a comparable qualification supported by job experience
  • Experience in Pharmacovigilance activities (preferably 2 + years)
  • Knowledge of local Pharmacovigilance and Regulatory legislation
  • Excellent written and verbal communication skills in English

  Additional Preferences:

  • Positive attitude and fit with Elanco cultural pillars
  • Demonstrated experience in working effectively with teams and various functional areas
  • Personal accountability and strong drive for execution
  • Accuracy and analytics mindset

  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

• About the company

  Elanco is a world leader in developing innovative products and solutions that enhance animal health, empowering the people that raise and care for animals

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