Regional Pharmacovigilance Associate (Temporal)

Job Description

The Associate Specialist, Pharmacovigilance will support the execution of activities associated with the Mexico Local ICSR Transition and Operational Stabilization Project. Under the supervision of the Country PV Lead or designated delegate, the incumbent will contribute to the implementation, stabilization and monitoring of local pharmacovigilance processes while ensuring compliance with applicable company procedures and local regulatory requirements.

Key Responsibilities

• Support implementation and stabilization of local Individual Case Safety Report (ICSR) management activities transferred to the Mexico affiliate, including acknowledgements, follow-up, translations and submissions according to local regulations and company procedures.
• Assist in the documentation, monitoring and continuous improvement of local case management processes required during the transition and stabilization phase.
• Support compliance monitoring activities, including tracking of key quality and timeliness metrics related to ICSR processing and reporting obligations.
• Assist in the preparation, maintenance and archival of pharmacovigilance documentation required to support project deliverables and local regulatory compliance.
• Support pharmacovigilance inspections, audits, issue management and corrective action activities associated with project objectives and compliance requirements.
• Contribute to implementation and maintenance activities related to Risk Management Plans (RMPs), aggregate safety reports, Post-Approval Safety Monitoring Programs (PSMPs) and other assigned pharmacovigilance deliverables, as required.
• Support translation and quality control of pharmacovigilance documents required for regulatory submissions and project activities.
• Participate in cross-functional initiatives, process harmonization activities and project-related deliverables that contribute to successful implementation of the local operating model.
• Complete all required training activities and maintain qualifications necessary to perform assigned responsibilities.

Requirements:

Bachelor Health and related.

Fluent English

PV knowledge (deseable)

Required Skills:

Budget Development, Change Management, Clinical Supply Chain Management, Clinical Trial Management, Data Analysis, Digital Marketing, Feasibility Studies, Issue Management, Office Tools, Operating Models, Pharmacovigilance, Project Human Resource Management, Project Management, Project Management Support, Project Management System, Project Management Tools, Project Planning, Project Resource Management, Regulatory Compliance, Regulatory Project Management, Risk Management, Risk Management Programs, Subcontract Management, Technical Quality Assurance

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:

Temporary (Fixed Term)

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:

08/11/2026

*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.