Product Safety Manager – PV (60%) Local Pharmacovigilance Associate for Germany, Austria and Switzerland (DACH) (40%)

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 cross-functional position supports both Product Safety Management and DACH Affiliate PV groups. The role may be levelled as P3 to P4 depending on experience.

Product Safety Manager

The Pharmacovigilance (PV) PSM provides leadership for and performs key functions within the Elanco Animal Health Global Pharmacovigilance Unit. The individual provides direction to internal and external partners in the collection, analysis, interpretation and reporting of adverse event (AE) data. In addition, the individual is responsible for collaborating with PV colleagues to develop a comprehensive signal detection and trending program to ensure product safety at a global level.

Local Pharmacovigilance Associate for Germany, Austria and Switzerland (DACH)

This role supports the Elanco PV organization for Germany, Austria and Switzerland (DACH), ensuring the Elanco DACH Pharmacovigilance team delivers their responsibilities on all PV issues and actions in the region. The role will be a member of the DACH Pharmacovigilance Team and will collaborate regionally and globally as required to ensure delivery of wider Elanco PV responsibilities. The role provides support for external contractors within the DACH region.

The role acts as the Local Pharmacovigilance Manager for Austria. In this capacity the role ensures the compliance of the Pharmacovigilance systems in Austria 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 DACH region to enhance value for both internal (e.g. commercial and regulatory teams) and external customers (including Regulatory Authorities). The Local PV Associate can delegate parts of his/her tasks to appropriately qualified and trained personnel. Nevertheless, the responsibility remains with the Local PV Associate.

Functions, Duties, Task:

General Requirements

• Work effectively and flexibly within and across all Elanco Innovation teams and external collaborators to achieve overall Elanco Innovation deliverables.
• Create a positive work environment that is aligned with company objectives.
• Provide and accept challenge to deliver innovative technical solutions and create an innovative culture.
• Identify and utilize methods to deliver individual objectives in a high quality, timely, cost-effective manner.
• Proactively identify and suggest improvement initiatives to support product safety, drive efficiency and compliance, and deliver value.
• As appropriate, represent Elanco GPV / DACH PV at regulatory agency meetings and industry working groups. Seize any opportunities to influence the external animal health.

Product Safety Manager

• Understand and ensure compliance with local and global PV Regulations.
• Participate in Signal Detection and Trending (SDT) for assigned products.
• Communicate SDT information as needed in region/affiliate/function.
• Collaborate within Global PV to implement/improve global strategy and work flow processes for assigned projects.
• Contributes to PV guidance/questions as assigned & ensure responses align with Global PV processes.
• Participate in case oversight process for cases as required.
• Liaise with quality to ensure appropriate connection between AEs and PCs.
• Review, analyze and interpret data to identify potential safety trends and signals in order to make recommendations for risk mitigation/management.
• Provide support for internal business partners by providing appropriate scientific/statistical interpretation of PV data. Ensure an accurate representation of the data collection and analysis process to internal customers.
• Prepare, interpret and present aggregate data to internal and external customers and global regulatory authorities, as appropriate.
• Provide interpretation of PV requirements to Elanco and contract personnel. Provide PV training and ongoing technical input to business partners (internal and external), as appropriate, regarding AE data contained within PV Works and other tools.
• Lead and/or support key PV projects to assure safety information drives labeling and promotional material changes for currently marketed products, as required.
• Proactively enhance work flow practices to increase data robustness while promoting efficiency.
• Provide support to the technical review and interpretation of scientific data. Leverage development team network to provide guidance to teams working on new product development.

Local Pharmacovigilance Associate for Germany, Austria and Switzerland (DACH)

DACH Region:

• Act as deputy for the Local Pharmacovigilance Manager for DACH , ensuring continuity for the DACH PV system in the absence of the Local Pharmacovigilance Manager (LPVM).
• Support the reporting of adverse events and product complaints in accordance with local regulatory and Elanco requirements. This includes providing support for external PV contractors in the DACH region.
• Support communication with the local RAs on topics related to the safety of Elanco products to ensure a timely response and clarity of message, collaborating with Elanco PV, Quality and Regulatory Affairs as required
• Deliver appropriate PV trainings to DACH region employees (including third parties with contractual arrangements for PV) on the local procedures for AE/PC reporting and other relevant PV topics.
• 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, support local literature review in line with local regulatory and Elanco requirements.
• Work with Elanco PV as required to facilitate review of local research and post marketing studies protocols to ensure compliance with PV reporting requirements.
• Support the preparation and maintenance of PV Agreements in the DACH region.
• Support PV audits and inspections in the DACH region, in conjunction with Elanco PV and Quality, and support execution of any corrective action plans. Proactively maintain the DACH region in an audit and inspection ready state.

• Austria:

• Act as Local Pharmacovigilance Manager for Austria
• Act as point of contact for, and provide visible leadership, for all PV matters in Austria.
• 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 Austria.
• Ensure the Austrian Regulatory Authority (RA) are informed of AE cases according to local regulatory and Elanco requirements, following the required process.
• Develop and maintain the relationship with the Austrian RA related to PV; act as the lead point of contact for the Austrian RA with regard to PV.
• Monitor changes to Austrian PV regulations, and ensure timely communication of this, and any other relevant safety related communication raised by a RA, to the Elanco PV Team.
• Act as local point of contact for third-parties in Austria with whom Elanco has PV Agreements (PVAs). With Elanco PV, ensure PVAs contain appropriate wording, and support compliance with terms of agreements (e.g. provision of training, reconciliation of cases, etc.).

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

• Bachelor’s Degree or higher within 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 German and English

  Additional Preferences:

• Desired, Doctor of Veterinary Medicine (DVM)
• 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

  Other Information:

  Expected travel: Up to 10%

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