Senior Pharmacovigilance Associate - Remote - ChileAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s general expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
As a Senior Pharmacovigilance Associate at ICON, you will be instrumental in ensuring the safety and efficacy of pharmaceutical products by managing and oversee pharmacovigilance activities.
What You Will Do:
You will take ownership of pharmacovigilance and drug safety deliverables, applying your expertise to complex challenges.
Key responsibilities include:
- 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.
Your Profile:
You will have a strong foundation in pharmacovigilance and drug safety, with the experience to work independently
📌 Senior Pharmacovigilance Associate (Santiago)
🏢 IRE
📍 Santiago