Pharmacovigilance Reporting Specialist
hace 2 semanas
Company Overview: ICON plc is a world-leading healthcare intelligence and clinical research organization. We pride ourselves on fostering an inclusive environment that drives innovation and excellence, welcoming talented individuals to join our mission in shaping the future of clinical development.
About the Role: As a Pharmacovigilance Reporting Specialist at ICON, you will play a crucial role in the accurate and timely preparation of safety reports related to clinical trials and post-marketing activities. Ensuring compliance with regulatory requirements, you will contribute to effective safety data management, supporting patient safety and regulatory compliance.
Your Key Responsibilities:
- Preparation and Review: Prepare and review safety reports, including periodic safety updates and individual case safety reports, ensuring accuracy and compliance with regulatory standards.
- Data Collection and Analysis: Collect and analyze adverse event data from clinical trials and post-marketing sources to support comprehensive safety report preparation.
- Regulatory Knowledge: Maintain up-to-date knowledge of regulatory requirements and industry best practices related to pharmacovigilance reporting.
- Cross-Functional Collaboration: Collaborate with cross-functional teams, including clinical, regulatory, and data management, to gather necessary information and resolve any reporting issues.
- Report Submission: Ensure timely submission of safety reports to regulatory authorities and sponsors, adhering to established deadlines and guidelines.
About You:
- Education: Bachelor's degree in life sciences, pharmacy, or a related field.
- Experience: Experience in pharmacovigilance or drug safety, with a strong understanding of safety reporting processes and regulatory requirements.
- Skills: Excellent attention to detail and organizational skills, with the ability to prepare and review complex safety reports accurately. Strong communication and collaboration skills, with experience working effectively within a multidisciplinary team.
We Offer: A competitive salary of £40,000 - £55,000 per annum, depending on experience. Our benefits package includes various annual leave entitlements, health insurance offerings, retirement planning, employee assistance program, flexible country-specific optional benefits, and more.
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