Job Description

We are leading innovator in the pharmaceutical industry dedicated to improving patient safety and product quality. We are currently seeking a highly skilled Senior Pharmacovigilance (PV) Specialist for a fixed-term position of 1 year to join our dynamic team. The successful candidate will play a key role in ensuring compliance with pharmacovigilance regulations while managing adverse event reporting and safety monitoring activities across supported countries.

Key Responsibilities:

Adverse Event Management: Oversee the management of adverse event reports, including the preparation and submission of individual case safety reports (ICSRs) and aggregate reports to health authorities.Compliance Monitoring: Conduct compliance checks and manage local pharmacovigilance agreements, ensuring adherence to local and global regulations.Health Authority Liaison: Serve as the primary contact for local health authorities regarding pharmacovigilance inquiries, acting as the local Qualified Person for Pharmacovigilance (QPPV) when required.Team Leadership: May manage direct reports, including recruitment, training, development, and performance management, fostering a culture of continuous improvement.Training and Development: Support the maintenance of the local PV training matrix, onboarding plans, and provide training to local staff, partners, and other stakeholders.Audit Support: Act as a Subject Matter Expert (SME) during local pharmacovigilance audits and inspections, ensuring readiness and compliance with CAPAs as needed.Document Management: Assist in the development and maintenance of local pharmacovigilance procedures, controlled documents, and ensure timely updates to the safety database and document archives.Safety Reporting: Responsible for reporting adverse experiences or product quality complaints, in compliance with company policies, and conducting literature screening for safety issues.Cross-Functional Collaboration: Liaise with internal and external stakeholders to communicate safety activities and ensure alignment with strategic decisions.

Qualifications:

Education: Degree in Health, Life Science, or Medical Science equivalent by education/experience (as per hiring manager discretion).Experience: Preference for candidates with experience in the pharmaceutical industry and knowledge of AE reporting requirements and pharmacovigilance regulatory frameworks.Leadership Skills: Strong supervisory experience managing teams or contractors, along with demonstrated leadership capabilities.Competencies:Fluent in English (written and spoken) and proficient in local language.Excellent interpersonal communication, organizational, and presentation skills.Ability to travel regionally and globally as necessary.Proven negotiation and influencing skills, with the ability to work independently while collaborating with others.

What We Offer:

Competitive salary and benefits package.Opportunity to work with a passionate team of professionals dedicated to patient safety and product quality.Professional development opportunities and the chance to contribute to meaningful projects within the healthcare sector.

If you are driven, detail-oriented, and ready to take on new challenges in pharmacovigilance, we invite you to apply for the Senior Pharmacovigilance Specialist role.

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:

Temporary (Fixed Term)

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

03/11/2025

*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:R337569