Product Safety Manager

Elanco•Indianapolis, IN

About The Position

The Product Safety Manager provides indirect leadership for and performs key functions within the Elanco Animal Health Global Pharmacovigilance Unit. The individual provides implementation and support to internal and external partners in analysis, interpretation and reporting of adverse event (AE) data. In addition, the individual is responsible for collaborating with PV colleagues to maintain a comprehensive signal management program to ensure product safety at a global level. This individual works effectively and flexibly within and across Elanco teams and external collaborators to achieve Elanco pharmacovigilance deliverables.

Requirements

Doctor of Veterinary Medicine (DVM), or PhD or equivalent experience.
A minimum of five years in clinical veterinary practice or animal health experience
Ability to evaluate large databases and design a system to extract datasets relevant to a variety of business needs.

Nice To Haves

A minimum of five years of PV experience in an animal health environment
Experience in interpretation of regulations, guidelines, and policies preferred

Responsibilities

Acts as subject matter expert of commercially available PV tools to further enhance the signal management process in Elanco.
Responsible for review, and analysis of individual case reports, aggregate safety data, signal detection, and risk management activities concerning the product portfolio.
Evaluates and interprets aggregate safety data for aggregate reports, signal management activities, Risk Management Plans, other labeling documentation and other routine and non-routine safety and benefit-risk evaluations for internal or regulatory purposes as required.
Represents Elanco in the preparation and participation of internal and external pharmacovigilance audits and inspections.
Ability to independently prioritize to ensure the objectives are achieved on time with efficient use of resources.
Staying current and providing forwarding thinking on signal management including interrogating external databases (e.g. open FDA, EVVET) to improve statistical power
Acts as a coach/mentor to provide expertise to other team members and external customers as applicable
Lead the technical review and interpretation of scientific data for assigned products as required.
Network with and provide guidance to teams working on new product development, global marketing, and hypercare teams
Is accountable for bringing suspected safety concerns, potential trends and signals to the appropriate safety committee, and making recommendations for risk mitigation/management.
Responsible for the preparation, interpretation and presentation of drug safety aggregate data reports, to internal and external customers and global regulatory authorities as required.
Leads or contributes to PV projects to assure safety information drives labelling and promotional material changes for currently marketed products, as required.
Leads training of less experienced internal and cross-functional team members, encouraging them to be successful and productive.
Able to summarize and present complex technical information succinctly to encourage increased understanding and contributions from others.
Contribute to the furthering of Pharmacovigilance Signal Management within the company by staying abreast of state-of-the-art methodology in the external environment, changes in the regulatory environment and developments.
Applies this knowledge for the benefit of the function.
Comply with all company local and global policies, including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and Health, Safety and Environment (HSE) policies
Create a positive work environment that is aligned with company objectives, visibly aligns work with company goals and encourages others to do the same.
Develops and drives the technical capabilities of self and team to improve PV decision making, particularly in areas of ambiguity.
Remains calm and productive when dealing with problems that do not have clear solutions, adapts quickly to changing conditions.
Support colleagues at affiliate sites to ensure pharmacovigilance compliance.
Perform any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training.