Full-Time Senior Pharmacovigilance Specialist

• Post-marketing product surveillance including proactive product monitoring, adverse event trending, signal detection and signal management.
• Provide risk assessments when applicable.
• Represent Pharmacovigilance in cross-functional product surveillance teams.
• Author safety review sections of regulatory reports.
• Build and maintain technical files within the global signal management system.
• Utilize technical tools with the Pharmacovigilance suite of software solutions.
• Provide innovative ideas and solutions to signal detection and signal management.
• Educate and train others on Global Pharmacovigilance Systems, Processes, and Procedures.
• Provide daily support, mentorship, and coaching to junior colleagues.
• Provide quality oversight for PV project team as assigned.

Requirements:

• Experience with EU Veterinary regulations and EudraVigilance preferred
• US Work Authorization
• DVM degree
• Minimum 5 years’ clinical veterinary practice or animal health experience.
• Experience with pharmacovigilance Signal Detection/Signal Management, data analytics, statistics, and/or epidemiology preferred.
• Knowledge of veterinary Pharmacovigilance regulations across multiple geographies preferred.
• Experience in preparation of regulatory submissions preferred.
• Experience in interpretation of regulations, guidelines, and policies preferred.

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