Product Safety Manager
On-siteIndianapolis, Indiana, United States
Job Summary
Conduct analysis and interpretation of adverse event data, aggregate safety reports, and risk management activities for the Elanco Animal Health global pharmacovigilance unit. Lead technical reviews of scientific data to drive labeling and promotional material changes, while managing signal detection and interrogating external databases like open FDA and EVVET. Represent the company in internal and external pharmacovigilance audits and inspections, ensuring compliance with global policies and regulatory frameworks. Act as a subject matter expert to coach team members and provide guidance to cross-functional teams in new product development and marketing. Accountable for bringing suspected safety concerns to safety committees and making recommendations for risk mitigation.
Required Qualifications
- 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
- Travel: up to 10%
Desired Qualifications
- Experience in interpretation of regulations, guidelines, and policies preferred
- A minimum of five years of PV experience in an animal health environment
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