Regional Pharmacovigilance Associate Specialist – LATAM Project

Job Description

Provide operational support to regional pharmacovigilance activities in LATAM, ensuring continuity, regulatory compliance, and process efficiency following recent regional organizational changes.

This role combines operational execution (case follow-up, literature review, and mailbox management) with a project component focused on process optimization and efficiency improvements.

Key Responsibilities

1. Case Management and Follow-up

• Perform follow-up activities for Individual Case Safety Reports (ICSRs)
• Contact healthcare professionals and patients to obtain additional information
• Ensure timely and complete documentation according to global PV procedures and LATAM HA requirements

2. LATAM PV Mailbox Management

• Perform daily review of the LATAM PV mailbox
• Classify and distribute incoming communications and cases
• Track and follow up on communications with countries and stakeholders

3. Literature Monitoring and Review

• Perform initial assessment of scientific literature relevant to pharmacovigilance
• Identify potential safety cases from literature

4. Support to Regulatory Reporting (as needed)

• Support submission of safety cases to Health Authorities across LATAM
• Coordinate with local PV teams when applicable
• Ensure compliance with regulatory timelines

5. Process Optimization (Project Component)

• Identify opportunities to improve efficiency in regional PV processes
• Support development and implementation of improvements (e.g., templates, trackers, automation)
• Document optimized workflows and best practices

Requirements:

Bachelor Health and related.

Fluent English

PV knowledge (deseable)

Required Skills:

Budget Development, Case Management, Change Management, Clinical Supply Chain Management, Clinical Trial Management, Data Analysis, Digital Marketing, Document Workflow, Drug Safety Surveillance, Feasibility Studies, Literature Reviews, Manufacturing Compliance, Office Tools, Operational Execution, Operations Coordination, Pharmacovigilance, Process Optimization, Project Management, Project Management Tools, Project Planning, Regulatory Compliance, Regulatory Reporting, Risk Management, Subcontract Management, Technical Quality Assurance

Preferred Skills:

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Employee Status:

Project Temps (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/7/2026

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