ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing medical innovation. With a strong commitment to excellence, ICON fosters an inclusive work environment that drives scientific progress and improves patient outcomes worldwide.
Job Description
Key Responsibilities:
- Review and process safety events (pre-marketing, post-marketing, medical devices, and drugs) as per project guidelines.
- Analyze abstracts and medical literature to identify safety information.
- Generate accurate data listings from safety databases.
- Conduct adverse event follow-ups via phone or written communication.
- Assist in developing Safety Management Plans and post-marketing safety reports (PSMF, RMP, PBRER).
- Support Qualified Person for Pharmacovigilance (QPPV) as needed.
- Collaborate with medical monitors, project managers, and sponsors on safety-related issues.
- Contribute to aggregated safety reports (DSUR, IND Annual Reports, PSURs).
- Perform SAE/AE reconciliation and database quality checks.
- Assist in signal detection and risk management activities.
- Support audits, inspections, and regulatory compliance efforts.
Qualifications & Skills:
- Education: Bachelor’s degree in Life Sciences, Pharmacy, or related field (Master’s preferred).
- Experience: Prior experience in pharmacovigilance, drug safety, or clinical research.
- Technical Skills: Proficiency in safety databases and medical literature review.
- Soft Skills: Strong analytical abilities, attention to detail, and excellent communication.
- Compliance: Knowledge of global pharmacovigilance regulations (ICH-GCP, FDA, EMA).
Why Join ICON?
ICON offers a dynamic work environment with opportunities for professional growth. Employees enjoy competitive benefits, including:
- Health Insurance: Comprehensive coverage for you and your family.
- Retirement Plans: Secure financial planning options.
- Work-Life Balance: Flexible leave policies and wellness programs.
- Global Support: 24/7 access to mental health and well-being services via LifeWorks.
- Additional Perks: Childcare vouchers, gym discounts, travel subsidies, and more.
How to Apply
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