Senior Pharmacovigilance Associate – Post-Marketing (FSP | Sponsor Dedicated)
Company: ICON Strategic Solutions
Location: Brazil (Remote / Home-Based)
Employment Type: Full-Time
Salary: Competitive
Start Date: 15 December 2025
Application Deadline: 22 December 2025
Experience Required: Minimum 5–7 years in Pharmacovigilance / Drug Safety
Job Overview
ICON Strategic Solutions, a global leader in healthcare intelligence and clinical research, is hiring a Senior Pharmacovigilance Associate – Post-Marketing for a sponsor-dedicated functional service partnership (FSP). This role is critical to ensuring patient safety and regulatory compliance for marketed pharmaceutical products.
The position offers a remote, home-based working model within Brazil and provides exposure to global pharmacovigilance operations in a highly regulated environment.
Key Responsibilities
Lead the collection, assessment, and processing of adverse event reports, ensuring accurate and timely submission in compliance with global regulatory requirements and internal SOPs.
Perform safety data analysis, identifying trends and potential safety signals that require escalation or further investigation.
Prepare, review, and submit Periodic Safety Update Reports (PSURs) and other post-marketing regulatory safety documents.
Collaborate with medical, clinical, and regulatory teams to evaluate the clinical relevance of adverse events and support risk management activities.
Ensure the accuracy, completeness, and integrity of pharmacovigilance databases and related documentation.
Support regulatory audits and inspections, ensuring continuous inspection readiness and compliance.
Provide training, technical guidance, and mentorship to junior pharmacovigilance staff.
Stay up to date with global pharmacovigilance regulations and industry best practices to support process improvement initiatives.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline; a postgraduate qualification is preferred.
At least 5–7 years of relevant experience in pharmacovigilance or drug safety, with strong exposure to post-marketing activities.
In-depth knowledge of global PV regulations and guidelines, including ICH, GVP, FDA, and EMA requirements.
Demonstrated experience in adverse event management, signal detection, and periodic safety reporting.
Proficiency in pharmacovigilance databases and safety data management systems, along with Microsoft Office tools.
Strong analytical, problem-solving, and decision-making skills.
Excellent written and verbal communication skills with the ability to collaborate across cross-functional and global teams.
Ability to work independently, manage multiple priorities, and meet strict timelines in a remote work environment.
High standards of professionalism with a strong commitment to data confidentiality and patient safety.
What ICON Strategic Solutions Offers
Competitive salary with country-specific benefits aligned to local market standards.
Comprehensive health insurance options for employees and dependents.
Generous annual leave entitlements and flexible work-life balance programs.
Retirement and long-term savings plans to support future financial security.
Access to the Global Employee Assistance Programme (LifeWorks), providing 24/7 professional support for employee well-being.
Life assurance and optional benefits such as wellness programs, fitness memberships, travel subsidies, and childcare support (country-specific).
An inclusive, performance-driven culture with strong opportunities for career development and long-term growth.
About ICON Strategic Solutions
ICON plc is a world-leading clinical research organization providing integrated solutions across the full clinical development lifecycle. ICON is committed to advancing healthcare through innovation, scientific excellence, and a strong focus on patient safety.
Equal Opportunity Statement
ICON is an equal opportunity employer and is committed to fostering an inclusive and accessible workplace. All qualified applicants will receive consideration without discrimination based on race, color, religion, gender, sexual orientation, gender identity, nationality, disability, or veteran status. Reasonable accommodations are available throughout the recruitment process.
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