Senior Pharmacovigilance Specialist.

Job Description

We are currently recruiting a Senior Pharmacovigilance (PV) Specialist. Under the direction of the applicable management, the Senior PV Specialist is responsible for Country PV activities (as delegated/assigned by their manager), which may include but are not limited to: PV intake, management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities,  review of local initiatives for compliance with PV requirements, SOP management, local training, communication of safety issues, people development, special projects as assigned and is able to work on these delegated activities independently.

The Sr. PV Specialist may serve as the backup (BU) local Qualified Person for PV (QPPV) / BU Local PV Contact / BU Local Responsible PV person as required per local PV legislation. In the absence of the PV Lead, they may manage day-to-day PV activities and serve as their backup.

Education

• Bachelors degree in Pharmacy or medicine.

Work Experience:

• Minimum 4 to 5 years of experience in pharmacovigilance, with experience in Pharmacovigilance Audits process, preferred.    

• Strong leadership, communication, decision-making, and problem-solving skills

• In-depth knowledge of AE reporting requirements and relevant PV regulations, PV quality management systems and be an expert in PV processes and activities.

• Experience with PV audits and/or PV Health Authority Inspections

Job‐specific competencies & skills:

• Must be fluent in English (written and spoken) while proficient in local language  

• Ability to travel within the region and globally.    

• Excellent interpersonal communications, organizational, and presentation skills

• Excellent negotiation and influencing skills

• Ability to work in partnership with others (internally and externally) to accomplish quality goals

• 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. 

• Demonstrates skills to drive change that enhances processes within the company or cross-functionally that improve quality and /or add value to the business. 

• Demonstrates strong strategic thinking and project management skills including prioritization of tasks.

Required Skills:

Adaptability, Adverse Event Report, Auditing, Compliance Monitoring, Data Analysis, Decision Making, Drug Safety Surveillance, Internal Inspection, Interpersonal Communication, IT Demand Management, Life Science, Pharmaceutical Management, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Prioritization, Project Management, Regulatory Compliance, Regulatory Reporting, Risk Management, Strategic Planning, Strategic Thinking, Training and Development, Veterinary Products, Working Independently

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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 relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

05/7/2026

*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.