Pharmacovigilance Assistant Ii
4 semanas atrás
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.
Locations:
- Colombia
- Sao Paolo, Brazil
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.
Your Profile:
- 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.
LI-FP1
What ICON can offer you:
- Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
- In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
- Our benefits examples include:
- 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
Visit our
careers site
to read more about the benefits ICON offers.
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