Pharmacovigilance Specialist

Job Description
We are currently looking for a

Pharmacovigilance Specialist
The Pharmacovigilance Specialist is responsible for specified Pharmacovigilance activities (as delegated/assigned by their manager) and is able to perform these tasks with minimal supervision. They are responsible for ensuring adherence to all applicable regulations, company policies and procedures.

Responsibilities

• Responsible for execution of local Pharmacovigilance processes and activities in collaboration with applicable internal functional areas and external parties, ensuring alignment with local legislation and local/regional/global company procedures and policies.
• Responsible for day-to-day adverse events case management which may include case intake, translations (English and/or local language), acknowledgments, follow-up and submission activities in accordance with pharmacovigilance procedures and country regulations.
• Supports local pharmacovigilance, business partner and vendor audits and inspections including readiness activities, document requests and CAPA activities.
• Participates in issue management/compliance activities and coordinates / prepares the necessary local corrective actions.
• Supports development and maintenance of local pharmacovigilance procedures and controlled documents in compliance with local, regional and global standards, to ensure global quality pharmacovigilance data.
• May be assigned responsibility for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations.
• May be responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements (as applicable).
• Support local implementation of applicable business continuity plans
• Responsible for filing, storage and archiving of safety-related documentation in accordance with company policies and local requirements.
• Translates or quality checks translation of applicable pharmacovigilance documents.
• Supports pharmacovigilance Lead in maintaining the local pharmacovigilance training matrix and onboarding plans.
• Liaises with the local business units to keep them apprised of safety activities and provides input on strategic decisions.
• Represents pharmacovigilance in cross-functional organizational and alliance partner forums as needed.

Qualifications

• Health, life science, or medical science degree or equivalent by education/experience
• At least 2 years of experience in pharmacovigilance is preferred
• General knowledge of adverse event reporting requirements and relevant pharmacovigilance regulations is required
• Must be fluent in English (written and spoken) while proficient in local language.
• Demonstrates proficiency in communication, organizational, and time management skills.
• Ability to work in partnership with others (internally and externally).
• Ability to interface broadly with colleagues within related functions and cross-functionally and be able to work independently with no supervision except in the most complex of situations.

We offer an attractive compensation package, outstanding benefits, and an exciting work environment with varied tasks in an international environment.

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)
Required Skills
Adaptability, Adaptability, Adverse Event Report, Bioethics, Biomedical Sciences, Clinical Trial Management, Communication, Complaint Management, Compliance Investigations, Cross-Functional Teamwork, Data Analysis, Data Management, Detail-Oriented, Drug Safety Surveillance, Employee Training, Hospital Medicine, IS Audit, Life Science, Management Process, Medical Teaching, Pharmaceutical Guidelines, Pharmaceutical Management, Pharmacovigilance, Regulatory Communications, Regulatory Compliance {+ 4 more}

Preferred Skills
Job Posting End Date
09/8/2025

• A job posting is effective until PM 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
R360707