Senior Pharmacovigilance Reporting Associate
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring recent 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 Reporting Associate at ICON, you will be essential in ensuring accurate and timely reporting of safety data related to pharmaceutical products.
What You Will Do:
Your experience in pharmacovigilance and drug safety will be key in delivering high-quality outcomes and mentoring colleagues.
Key responsibilities include:
Preparing and submitting adverse event reports and safety data in accordance with regulatory requirements and internal policies, ensuring accuracy and completeness.
Collaborating with clinical and regulatory teams to review and analyze safety data, identifying trends and potential safety signals for further investigation.
Assisting in the preparation of periodic safety update reports (PSURs), annual reports, and other regulatory documents to ensure compliance with reporting obligations.
Monitoring timelines for safety report submissions and proactively managing any delays or issues that may arise in the reporting process.
Maintaining and updating pharmacovigilance databases, ensuring the integrity and quality of safety data through meticulous data entry and validation.
Providing training and support to junior team members on reporting procedures and pharmacovigilance regulations to enhance team capabilities.
Engaging in audits and inspections by regulatory authorities, ensuring readiness and adherence to all relevant pharmacovigilance reporting requirements.
Your Profile:
You will have a solid foundation in pharmacovigilance and drug safety, with the experience to work independently and guide others.
Required qualifications and ex
📌 Senior Pharmacovigilance Reporting Associate Chennai
🏢 IRE
📍 Chennai
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