Senior Specialist, Drug Safety - Animal Health

Key Responsibilities: Depending on specific portfolio assignments and organizational needs, responsibilities will encompass some or all of the following areas: Case Management and Regulatory Submissions 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. Signal Management and Risk Assessment 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. Database and System Administration 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. Compliance, Quality, and Team Activities 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.

Required Qualifications: 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.

Preferred Qualifications: 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.

Required Skills: Adverse Event Report, Collaboration Tools, Compliance Monitoring, Drug Safety Surveillance, Evaluating Applications, Medication Safety, Pharmacovigilance, Product Security, Regulatory Audits, Regulatory Compliance, Risk Management, Risk Mitigation Strategies, Safety Audits, Safety Reporting, Strategic Planning, Team Organization, Training and Development

Preferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your RightsEEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State ActsThe salary range for this role is$117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular

Relocation: No relocationVISA Sponsorship: NoTravel Requirements:10%Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Location: USA - New Jersey - Rahway

Type: Full time