06 sep
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Ciudad de México
06 sep
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Ciudad de México
Home based - CDMX
ICON is a integral healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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:
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 and guide others.
Required qualifications and experience:
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Extensive experience in pharma
📌 Senior Pharamacovigilance Associate (Ciudad de México)
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