Drug Safety Associate – Pharmacovigilance
Employer: ICON Strategic Solutions
Parent Organization: ICON plc
Location: Buenos Aires, Argentina (Hybrid – Homeworking with Office Presence 3 Days/Week)
Employment Type: Full-Time
Start Date: 25 February 2026
Application Deadline: 27 March 2026
Compensation: Competitive Salary Package
About the Organization
ICON plc is a global leader in healthcare intelligence and clinical research services, partnering with pharmaceutical, biotechnology, and medical device companies to accelerate drug development and ensure patient safety. Through ICON Strategic Solutions, ICON delivers strategic functional service solutions across global markets.
Role Overview
The Drug Safety Associate (Pharmacovigilance) will support global safety surveillance activities by processing adverse event reports, ensuring regulatory compliance, and maintaining high-quality pharmacovigilance documentation. This role is critical in safeguarding patient health and supporting clinical development programs across therapeutic areas.
This is a hybrid position based in Buenos Aires, requiring office presence three times per week.
Key Responsibilities
Collect, review, and process adverse event (AE) reports from clinical trials and post-marketing sources.
Perform case triage, initial medical assessment, and MedDRA coding in accordance with internal SOPs and global regulatory requirements.
Prepare and submit expedited safety reports to regulatory authorities and investigators within defined timelines.
Maintain and update safety databases and tracking systems to ensure data integrity and audit readiness.
Ensure compliance with global pharmacovigilance regulations including ICH guidelines and regional health authority requirements.
Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, and Medical teams for accurate and timely reporting.
Support inspection readiness activities and quality assurance initiatives.
Educational Qualification
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Nursing, or a related healthcare/scientific discipline.
Experience Required
1–2 years of experience in Pharmacovigilance, Drug Safety, or Clinical Safety within a pharmaceutical, biotechnology, or CRO environment preferred.
Practical experience in adverse event case processing and regulatory safety reporting is advantageous.
Familiarity with safety databases and global reporting timelines preferred.
Core Competencies
Adverse Event Case Processing
Pharmacovigilance Compliance
MedDRA Coding & Safety Databases
Regulatory Reporting (ICH and Regional Guidelines)
Data Accuracy & Quality Control
Cross-Functional Communication
Time Management in Fast-Paced Environments
Compensation & Benefits
ICON plc offers a competitive compensation structure along with comprehensive benefits designed to support employee well-being and work-life balance. Benefits may include:
Annual leave entitlements
Health insurance options for employees and dependents
Retirement savings plans
Global Employee Assistance Program (EAP)
Life assurance coverage
Flexible country-specific benefits such as wellness initiatives, childcare support, gym discounts, and travel subsidies
Equal Opportunity Statement
ICON is committed to maintaining an inclusive and discrimination-free workplace. All qualified applicants will receive equal employment consideration regardless of race, gender, religion, disability, veteran status, or any legally protected characteristic.
Advance your Pharmacovigilance career with a globally recognized clinical research organization.
Discover more Drug Safety, Pharmacovigilance, Clinical Research, and Regulatory Affairs jobs worldwide at ThePharmaDaily.com.
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