Regulatory and Pharmacovigilance Specialist

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your role: Regulatory and Pharmacovigilance Specialist
 

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

Works closely with Global Pharmacovigilance Team to provide support to local regulatory and sales organization in fulfilling local Pharmacovigilance (PV) requirements.

In Regulatory capacity, the role is responsible for maintaining life cycle of existing product registrations and ensure in-time submission and approval of new products registrations in Turkey, also ensure 100 % compliance of product registrations and packaging materials with the local legislation.

Your 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 to date information about regulatory requirements in response to any intra-company internal request.


* Prepare dossier documents, arrange translation, complete registration dossiers for existing and new products submissions in accordance with yearly registration plan, to ensure in-time receiving of approval documents.


* Ensure regulatory compliance of printed packaging materials


* Prepare responses to official requests received from the Local Regulatory authorities.


* To review and ensure compliance of local promoti...