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 strong 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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