Safeguard Patient Safety at the Heart of Clinical Development
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 seeking a meticulous and dedicated Drug Safety Associate to join our global Pharmacovigilance team. In this vital role, you will be responsible for the accurate and timely processing of safety information, directly contributing to the protection of patient safety and the advancement of innovative treatments. This is an excellent opportunity to build a career in a critical and growing field.
Your Responsibilities: What You Will Be Doing
- Case Processing & Triage: Collect, review, and perform initial assessment of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing sources.
- Medical Coding: Accurately code adverse events and medications using standard medical dictionaries (MedDRA, WHODrug) in accordance with regulatory guidelines.
- Regulatory Reporting: Assist in the preparation and submission of expedited safety reports (e.g., SUSARs, 7/15-day reports) to regulatory authorities, ethics committees, and investigators.
- Database & Systems Management: Support the development, maintenance, and quality control of pharmacovigilance databases and safety tracking systems.
- Cross-Functional Collaboration: Work closely with clinical operations, data management, and medical teams to ensure the integrity and timely flow of safety data.
Your Profile: Qualifications & Skills
Education & Experience:
- A Bachelor's degree in Pharmacy, Life Sciences, Nursing, or a related healthcare/scientific field.
- 1-2 years of experience in pharmacovigilance or drug safety within a pharmaceutical, biotechnology, or CRO environment is highly preferred. Motivated entry-level candidates with relevant academic background are also encouraged to apply.
- Knowledge of global pharmacovigilance regulations (ICH E2, FDA, EMA) is advantageous.
Key Competencies:
- Exceptional Attention to Detail: Ability to review complex medical information with high accuracy.
- Strong Organizational Skills: Capable of managing multiple tasks, meeting strict deadlines, and prioritizing effectively in a fast-paced environment.
- Excellent Communication Skills: Clear written and verbal communication, with the ability to collaborate effectively in a global, cross-functional team.
- Proactive & Adaptable: A quick learner with a commitment to quality and patient safety.
Why Join ICON?
Our success depends on the quality of our people. That’s why we prioritize building a diverse culture that rewards high performance and nurtures talent.
We Offer a Competitive Benefits Package Focused on Well-Being:
- Generous Annual Leave entitlements.
- Comprehensive Health Insurance options for you and your family.
- Competitive Retirement Planning offerings to secure your future.
- Global Employee Assistance Programme providing 24/7 confidential support.
- Life Assurance coverage.
- Flexible, Country-Specific Benefits which may include wellness programs, subsidized travel, and more.
Our Commitment to You:
At ICON, inclusion and belonging are fundamental to our culture and values. We are dedicated to providing an inclusive and accessible environment and are proud to be an equal opportunity employer.
Ready to start a meaningful career ensuring the safety of medicines that improve patient lives?
Apply now for the Drug Safety Associate position.
We encourage all interested candidates to apply. If you require a reasonable accommodation during the application process, please inform us.
