Senior Pharmacovigilance Associate – Post-Marketing (FSP, Sponsor Dedicated)
Employer: ICON Strategic Solutions
Location: Brazil (Remote / Home-Based)
Employment Type: Full-Time
Salary: Competitive, based on experience
Start Date: 15 December 2025
Application Deadline: 14 January 2026
Job Overview
ICON Strategic Solutions, a global leader in healthcare intelligence and clinical research, is seeking an experienced Senior Pharmacovigilance Associate – Post-Marketing to join its sponsor-dedicated Functional Service Partnership (FSP) team. This remote opportunity based in Brazil offers the chance to work on global post-marketing safety activities while contributing directly to patient safety and regulatory compliance.
As a Senior Pharmacovigilance Associate, you will play a key role in managing end-to-end pharmacovigilance processes, ensuring accurate adverse event reporting, regulatory compliance, and proactive safety signal management in accordance with international guidelines.
Key Responsibilities
Lead the collection, assessment, and processing of post-marketing adverse event reports in compliance with global regulatory requirements and internal SOPs
Perform medical review and data analysis of safety cases to identify trends, risks, and potential safety signals
Prepare, review, and submit regulatory safety documents including PSURs/PBRERs and other post-authorization safety reports
Collaborate with medical, clinical, and regulatory teams to support benefit-risk evaluation and risk management activities
Ensure accuracy, completeness, and integrity of safety data within pharmacovigilance databases
Support internal and external audits, inspections, and regulatory authority interactions
Mentor and guide junior pharmacovigilance team members on safety processes and best practices
Stay current with evolving global pharmacovigilance regulations, including ICH, FDA, EMA, and local authority requirements
Required Qualifications and Experience
Bachelor’s degree in Pharmacy, Life Sciences, Nursing, Medicine, or a related discipline (Master’s degree preferred)
Minimum 4–6 years of hands-on experience in pharmacovigilance or drug safety, with strong exposure to post-marketing surveillance
Solid understanding of global PV regulations and guidelines (ICH E2 series, GVP modules, FDA requirements)
Proven experience in adverse event case processing, medical review, and safety reporting
Familiarity with leading pharmacovigilance databases and safety systems
Strong analytical, problem-solving, and decision-making skills
Excellent written and verbal communication skills in a global, cross-functional environment
Ability to manage multiple priorities independently in a fast-paced, remote setting
High ethical standards with strict attention to data privacy and patient confidentiality
What ICON Strategic Solutions Offers
ICON is committed to building a high-performance, inclusive culture that supports professional growth and work-life balance. Employees benefit from:
Competitive compensation packages aligned with local markets
Generous annual leave policies
Comprehensive health insurance options for employees and families
Retirement and long-term financial planning benefits
Global Employee Assistance Program (LifeWorks) with 24/7 professional support
Life assurance coverage
Flexible, country-specific benefits such as wellness programs, childcare support, transportation subsidies, and fitness discounts
Diversity, Equity, and Inclusion
ICON is an equal opportunity employer committed to fostering an inclusive and accessible workplace. All qualified applicants will be considered without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status. Reasonable accommodations are available throughout the recruitment process upon request.
Apply Now
Candidates who may not meet every listed requirement are still encouraged to apply. ICON values potential, diversity of experience, and a passion for improving patient safety.
Current ICON employees should apply through the internal career portal.
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