ICON plc seeks a Senior Pharmacovigilance Associate to play an instrumental role in ensuring the safety and efficacy of pharmaceutical products. In this position, you will manage and oversee pharmacovigilance activities, collaborating with cross-functional teams to ensure compliance with regulatory requirements and maintain the highest standards of patient safety.

What You'll Do

Lead the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting.
Conduct thorough data analysis and interpretation of safety data, identifying trends and potential safety signals.
Prepare and submit comprehensive periodic safety update reports (PSURs) and other regulatory documents.
Collaborate with medical and clinical teams to assess the clinical relevance of reported adverse events.
Oversee the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation.
Provide training and mentorship to junior team members on pharmacovigilance processes and best practices.
Engage in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance.
Stay informed on evolving regulatory guidelines to continually enhance pharmacovigilance processes.

What We're Looking For

Bachelor’s degree in life sciences, pharmacy, nursing, or a related field.
High level of English proficiency.
Based in Brazil.
Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations.
Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection.
Strong analytical and critical thinking skills, with the ability to interpret complex data.
Excellent communication and interpersonal skills, with the ability to work collaboratively across teams.
Proficiency in pharmacovigilance databases, data management systems, and Microsoft Office Suite.
Ability to work independently and manage multiple priorities in a fast-paced environment.
Commitment to maintaining confidentiality and handling sensitive patient information with discretion.

Nice to Have

An advanced degree.

Technical Stack

Pharmacovigilance databases
Data management systems
Microsoft Office Suite

Team & Environment

You will join a diverse and dynamic team within a global organization.

Benefits & Compensation

Competitive salary.
Various annual leave entitlements.
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to support.
Life assurance.
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, and health assessments.

Work Mode

This position is part of our global operations and is based in Brazil.

ICON plc is an equal opportunity employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.