Senior Pharmacovigilance Associate – Post-Marketing (FSP | Sponsor Dedicated)
Function: Pharmacovigilance / Drug Safety
Company: ICON Strategic Solutions
Location: Brazil (Remote / Home-Based)
Employment Type: Full-Time
Salary: Competitive (Country-aligned benefits)
Start Date: 15 December 2025
Application Deadline: 22 December 2025
Experience Required: 5–7+ Years in Pharmacovigilance / Drug Safety
Role Overview
ICON Strategic Solutions is seeking an experienced Senior Pharmacovigilance Associate – Post-Marketing to support sponsor-dedicated pharmacovigilance activities. This role plays a critical part in ensuring the ongoing safety, compliance, and risk management of marketed pharmaceutical products.
The position is fully remote within Brazil and offers the opportunity to work closely with global cross-functional teams in a fast-paced, compliance-driven environment. You will contribute directly to patient safety, regulatory adherence, and continuous improvement of post-marketing surveillance processes.
Key Responsibilities
Lead the collection, evaluation, and processing of adverse event reports, ensuring timely and compliant reporting according to global regulatory requirements and sponsor SOPs.
Perform in-depth analysis and interpretation of post-marketing safety data, identifying trends, safety signals, and areas requiring escalation.
Prepare, review, and submit Periodic Safety Update Reports (PSURs) and other post-marketing regulatory safety documents.
Collaborate with medical, clinical, and regulatory stakeholders to assess the clinical relevance of adverse events and support risk management strategies.
Maintain and oversee the accuracy and integrity of pharmacovigilance databases, ensuring compliance with data governance standards.
Support and participate in regulatory audits and inspections, ensuring inspection readiness and documentation compliance.
Provide training, guidance, and mentorship to junior pharmacovigilance team members.
Stay current with evolving global PV regulations and industry best practices, contributing to continuous process optimization.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline; advanced degree preferred.
Minimum 5–7 years of hands-on pharmacovigilance or drug safety experience, with strong exposure to post-marketing surveillance.
Proven expertise in adverse event management, signal detection, and periodic safety reporting.
Strong working knowledge of global pharmacovigilance regulations (ICH, GVP, FDA, EMA).
Experience working with pharmacovigilance databases and safety data management systems.
Excellent analytical, problem-solving, and decision-making skills.
Strong written and verbal communication skills, with the ability to collaborate across global teams.
Ability to manage multiple priorities independently in a remote, fast-paced environment.
High level of professionalism, discretion, and commitment to patient data confidentiality.
Why Join ICON Strategic Solutions
Fully remote role with global exposure and sponsor-dedicated engagement.
Opportunity to work with a leading global CRO recognized for innovation and quality.
Competitive compensation with country-specific benefits focused on well-being and work–life balance.
Access to professional development, training, and long-term career growth in pharmacovigilance.
Inclusive, diverse, and collaborative work culture committed to excellence and integrity.
About ICON Strategic Solutions
ICON plc is a global leader in healthcare intelligence and clinical research, supporting pharmaceutical, biotechnology, and medical device companies across the full product lifecycle. ICON is committed to advancing clinical development through scientific rigor, innovation, and a people-first culture.
Equal Opportunity Statement
ICON is an equal opportunity employer and is committed to providing an inclusive and accessible work environment. All qualified applicants will receive consideration without regard to race, gender, age, disability, nationality, or any other protected characteristic. Reasonable accommodations are available throughout the recruitment process upon request.
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