Senior Pharmacovigilance Associate

• Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies
• Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation
• Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations
• Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities
• Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards
• Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices
• Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements
• Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field
• High level of English proficiency
• Based on Brazil - 100% remote position
• Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards
• 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 and make informed recommendations
• Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams
• Proficiency in pharmacovigilance databases and data management systems, as well as 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

An advanced degree is preferred

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support 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, among others