Senior Specialist, Drug Safety - Animal Health

Merck • Rahway, NJ

7d • $117,000 - $184,200 • Hybrid

About The Position

We are seeking a highly skilled and collaborative Senior Specialist to join our Animal Health Global Pharmacovigilance (GPV) team. In this role, you will contribute as a drug safety expert, participating in safety surveillance, risk assessment, and regulatory compliance for our animal health product portfolio.

Requirements

• Doctor of Veterinary Medicine (DVM, VMD, or equivalent).
• Minimum of 2 years of clinical veterinary practice experience.
• Strong analytical, communication, and technical writing skills.
• Ability to manage competing priorities within global cross-functional teams.
• Proficiency in Microsoft Office.

Nice To Haves

• Knowledge of veterinary pharmacovigilance regulations and guidelines
• Hands-on experience with safety databases; PV-Works experience is strongly preferred.
• Proven expertise in adverse event evaluation, veterinary safety review, and signal detection methodology.
• Familiarity with veterinary biostatistics, epidemiology, clinical trial data, and audit and corrective and preventive action processes.
• Exposure to modern digital collaboration tools and artificial intelligence applications.

Responsibilities

• Perform comprehensive review and approval of adverse event cases and ensure timely case submissions to global regulatory authorities.
• Participate in aggregate report and pharmacovigilance statement preparation.
• Provide support to national pharmacovigilance teams.
• Serve as the product expert for assigned products.
• Critically analyze peer-reviewed veterinary literature and clinical study pharmacovigilance data and protocols.
• Participate in signal management activities, including signal detection, prioritization, validation, assessment, and recommendation for action.
• Author Signal Management Statements and, if applicable, submit documentation to Competent Authorities in accordance with statutory timelines.
• Participate in risk communication planning and the development of targeted risk minimization strategies.
• Support product maintenance within the global safety database.
• Provide business support for pharmacovigilance database systems, including reviewing validation documents and executing User Acceptance Tests for functionality changes and system enhancements.
• Actively participate in departmental, cross-functional, and project team meetings.
• Participate in internal audits and external regulatory inspections and support corrective and preventive action completion activities as applicable.
• Support Global Pharmacovigilance procedure management and training initiatives.
• Participate in special projects and initiatives.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree