Senior Pharmacovigilance Specialist

Eurofins • Kalamazoo, MI

90d

About The Position

Post-marketing product surveillance to include but not limited to 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 or other communication when required. 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 evolving signal detection and signal management landscape. Educate and train others on Global Pharmacovigilance Systems, Processes, and Procedures as applicable. Provide daily support and mentorship and coaching to junior colleagues. Provide quality oversight for PV project team as assigned.

Requirements

• 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.

Nice To Haves

• Experience with EU Veterinary regulations and EudraVigilance preferred.

Responsibilities

• 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 or other communication when required.
• 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 evolving signal detection and signal management landscape.
• Educate and train others on Global Pharmacovigilance Systems, Processes, and Procedures as applicable.
• Provide daily support and mentorship and coaching to junior colleagues.
• Provide quality oversight for PV project team as assigned.

Benefits

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree