ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to advancing and improving patients’ lives. With a commitment to innovation, excellence, and inclusivity, ICON fosters a dynamic work environment where talented professionals collaborate to shape the future of clinical development.
Our ‘Own It’ culture is built on four core values:
- Accountability & Delivery
- Collaboration
- Partnership
- Integrity
We strive to be the partner of choice in drug development, delivering excellence at every stage of clinical research.
Job Description
We are seeking a Drug Safety Physician to provide medical and safety expertise, ensuring projects adhere to the highest ethical, regulatory, and pharmacovigilance standards (GCP, GVP).
Key Responsibilities:
✔ Review and assess adverse events (AEs) and adverse drug reactions (ADRs) for seriousness, expectedness, and relatedness.
✔ Evaluate aggregated safety reports (e.g., PSURs, PBRERs, DSURs) to identify product safety trends.
✔ Provide medical expertise on safety issues in clinical trials and post-marketing settings.
✔ Support regulatory reporting (expedited and periodic) for AEs/ADRs from trials, spontaneous reports, and literature.
✔ Review Project-Specific Procedures and contribute to safety-related discussions.
✔ Collaborate with clients on Core Data Sheets (CCDS), Product Information (PI), and labeling updates.
✔ Train and guide teams on pharmacovigilance regulations and best practices.
Requirements:
- Medical degree (MBBS/MD) with 2-3 years of clinical experience (hospital-based practice preferred).
- Prior experience in pharmacovigilance or clinical research (optional but advantageous).
- Strong knowledge of MedDRA coding, GCP, and GVP guidelines.
- Excellent analytical and communication skills.
Why Join ICON?
At ICON, we invest in our people. We offer:
✅ Competitive salary & performance-based bonuses
✅ Health insurance & wellness programs
✅ Retirement plans & life assurance
✅ Flexible work options (Office with Flex)
✅ Global Employee Assistance Program (24/7 support)
✅ Continuous learning & career growth opportunities
We are an equal opportunity employer, committed to diversity and inclusion.