Job Description
We are looking for a Pharmacovigilance Specialist responsible for executing and ensuring local PV activities, guaranteeing compliance with applicable regulations, as well as company policies and procedures.
This role operates with a high level of autonomy in the day-to-day management of safety activities and works closely with internal teams, business partners, and regulatory authorities.
Key Responsibilities:
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Execute local pharmacovigilance processes, ensuring alignment with applicable regulations and global standards.
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Manage adverse event cases end-to-end (intake, assessment, follow-up, and reporting).
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Coordinate aggregate safety reports and support post-marketing safety monitoring programs.
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Participate in audits and inspections, including preparation, documentation support, and CAPA follow-up.
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Contribute to continuous improvement through the development and maintenance of local PV procedures.
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Support implementation of risk minimization measures and Risk Management Plans (RMPs), as applicable.
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Act as a local PV subject matter expert, providing guidance to internal teams and participating in cross-functional initiatives.
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Ensure compliance with activities such as literature review, health authority monitoring, and document management.
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Support business continuity plans and training activities.
Profile:
Professional with experience in pharmacovigilance, strong focus on quality and compliance, able to work independently, influence cross-functional teams, and maintain a strong patient safety mindset.
Required Skills:
Adaptability, Adverse Event Report, Business Continuity, Clinical Trial Management, Complaint Management, Compliance Investigations, Data Analysis, Data Management, Detail-Oriented, Driving Continuous Improvement, Drug Safety Surveillance, Employee Training, Patient Safety, Periodic Safety Update Reports, Pharmacovigilance, Quality Control Management, Regulatory Communications, Regulatory Compliance, Risk Management, Risk Models, Safety Management, Standards Compliance, Veterinary Products
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
06/13/2026
- A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R401733
