Pharmacovigilance Assistant I
Job details
Pharmacovigilance Assistant I ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Pharmacovigilance Assistant II to join our diverse and dynamic team. As a Pharmacovigilance Assistant II at ICON, you will play a critical role in ensuring the accurate collection, processing, and reporting of safety data for clinical trials and marketed products. You will contribute to compliance with global regulatory requirements and help safeguard patient safety in ongoing research and post-marketing activities. What You Will Be Doing:
- Overseeing the collection, processing, and timely reporting of adverse event reports in compliance with regulatory requirements.
- Ensuring accurate data entry and maintenance of pharmacovigilance databases, reviewing reports for consistency and completeness.
- Assisting in the preparation of periodic safety reports, including risk-benefit analyses, for regulatory submissions and sponsors.
- Collaborating with internal teams and external stakeholders to resolve queries related to safety data and pharmacovigilance activities.
- Supporting audit and inspection readiness by maintaining comprehensive documentation of pharmacovigilance activities and safety reports.
- Bachelor’s degree in life sciences, pharmacy, or a related field.
- Previous experience in pharmacovigilance or drug safety, with a solid understanding of regulatory requirements and safety reporting processes.
- Excellent attention to detail and strong organizational skills, with the ability to manage complex data sets and reports.
- Strong communication and teamwork skills, with experience collaborating across cross-functional teams and external partners.
- Ability to work in a fast-paced environment, ensuring compliance with regulatory guidelines and timelines.
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
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