[Hiring] Senior Pharmacovigilance Associate @ICON plc

Role Description

As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and overseeing pharmacovigilance activities.

What You Will Do:

• Take ownership of pharmacovigilance and drug safety deliverables, applying your expertise to complex challenges.
• Lead the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies.
• Conduct thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation.
• Prepare and submit comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations.
• Collaborate with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities.
• Oversee the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards.
• Provide training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices.
• Engage in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• 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.
• Advanced level of English.
• Based in Buenos Aires - Remote position.

Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.