Senior Pharmacovigilance Associate

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Leading the gathering, assessment, and processing of adverse event reports to guarantee timely and precise reporting in alignment with regulatory guidelines and company policies.

• Performing detailed data analysis and interpretation of safety data, recognizing trends and potential safety signals that necessitate further investigation.

• Compiling and submitting detailed periodic safety update reports (PSURs) and other regulatory documents, ensuring adherence to international regulations.

• Collaborating with medical and clinical teams to evaluate the clinical significance of reported adverse events and contribute to risk management efforts.

• Supervising the upkeep and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.

• Offering training and mentorship to junior team members regarding pharmacovigilance processes, regulatory requirements, and best practices.

• Participating in audits and inspections conducted by regulatory authorities, ensuring preparedness and compliance with all pertinent pharmacovigilance requirements.

• Keeping abreast of changing regulatory guidelines and industry best practices to continually improve the pharmacovigilance processes within the organization.

⛳️ Requirements

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related discipline.

• An advanced degree is preferred.

• Extensive experience in pharmacovigilance or drug safety, with a robust understanding of relevant regulations and industry standards.

• Demonstrated ability to effectively manage the pharmacovigilance process, including adverse event reporting and signal detection.

• Proficiency in pharmacovigilance databases and data management systems, along with Microsoft Office Suite.

• Trilingual, with required proficiency in Portuguese, Spanish, and English.

• A minimum of 2 years of experience in case processing and resolution.

🏝️ Benefits

• Various annual leave entitlements.

• A range of health insurance options to meet you and your family’s needs.

• Competitive retirement planning options to maximize savings and prepare with confidence for the future.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a worldwide network of over 80,000 independent specialized professionals dedicated to supporting you and your family’s well-being.

• Life assurance.

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.