Regional Pharmacovigilance Officer

Job Description

The "Senior Specialist, Regional Pharmacovigilance Officer - Latin America/Canada" is responsible for specified activities that support the Pharmacovigilance Country Leads, Cluster Leads and Pharmacovigilance Regional Head in the Latin America/Canada Region.

The position reports to the Director, Lead of the Regional Pharmacovigilance Officer Organization

In addition to country level support, the Sr Specialist, Regional Pharmacovigilance Officer is a subject matter expert (SME) for identified activities. This role interacts with global PV colleagues, as well as with colleagues in Global Clinical Trial Operations (GCTO), Regulatory Affairs International (RAI), Global Medical and Scientific Affairs (GMSA), and other business unit colleagues in their region

Responsibilities include:

• Act as SME for identified country/regional PV activities

• Country level audits and inspections and CAPA development

• Support and guidance for Q&C activities e.g., compliance and issue management

• Safety Database system and process expertise and support e.g. with reportability rules

• Preparation, review and maintenance of local, regional and international PV procedures

• Local PV contract management support and Regional contract management activities

• Supporting PV Intelligence monitoring, interpretation, and implementation

• Oversight and collation of regulatory requirements to support business activities

• Support for EU PSMF and local PSMF maintenance

• Support of ARMM implementation, and compliance monitoring

• Participate in regional meetings (e.g., routine and annual meetings)

• May participate in project activities

• May serve as back-up to a PV Lead for certain activities as needed during periods of absence

Qualifications, skills and experience required:

Education: 

• Health, life science, or medical science degree or equivalent by education/experience (Hiring Manager discretion permitted) 

Work Experience:  

• At least 2 years of experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities is preferred (Hiring Manager discretion permitted) 

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

• 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:  

• Technology savviness and a passion for innovation

• 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 minimal supervision

This position can be based in any location in the Latin America/Canada region.

In-office/Hybrid working model will be determined by the policy in place in the employee's work location/country.

Required Skills:

Adaptability, Adverse Event Report, Auditing, Business Process Improvements, Compliance Monitoring, Data Analysis, Decision Making, Drug Safety Surveillance, Financial Process Improvement, IS Audit, Pharmaceutical Regulatory Compliance, Pharmacovigilance, Regulatory Compliance, Regulatory Reporting, Risk Management, Strategic Planning, Training and Development, Veterinary Products

Preferred Skills:

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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):

NA

Job Posting End Date:

04/21/2026

*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.