ICON plc is a global leader in healthcare intelligence and clinical research, dedicated to driving innovation in clinical development. With a commitment to excellence and inclusivity, ICON fosters a dynamic work environment where professionals can thrive and contribute to shaping the future of patient care.
Job Description
ICON plc is seeking a Pharmacovigilance Associate or Sr. Pharmacovigilance Associate to join their team in Chennai. This role involves reviewing and processing safety events, ensuring compliance with regulatory guidelines, and supporting pharmacovigilance activities for both pre-marketing and post-marketing products.
Key Responsibilities:
✔ Review and process adverse event (AE) reports for drugs and medical devices.
✔ Perform literature reviews (abstracts & full articles) to identify safety data.
✔ Generate safety data listings and ensure database accuracy.
✔ Conduct follow-ups on adverse events via phone or written communication.
✔ Support safety management plans, including Risk Management Plans (RMP), PSMF, and PBRERs.
✔ Assist in signal detection, risk assessment, and safety report generation (DSUR, PSUR, etc.).
✔ Liaise with medical monitors, sponsors, and investigators on safety-related issues.
✔ Support audits, inspections, and regulatory submissions as needed.
✔ Handle medical information inquiries related to product safety.
Qualifications & Skills:
✅ Bachelor’s/Master’s degree in Life Sciences, Pharmacy, or related field.
✅ Experience in pharmacovigilance/drug safety (clinical research or pharma preferred).
✅ Strong analytical skills with attention to detail.
✅ Excellent communication (written & verbal) and teamwork abilities.
✅ Knowledge of global pharmacovigilance regulations (FDA, EMA, etc.).
Why Join ICON?
ICON offers a competitive salary and benefits, including:
- Health insurance for you and your family.
- Retirement planning and life assurance.
- Global Employee Assistance Program (EAP) for mental health support.
- Flexible benefits (childcare vouchers, gym discounts, travel passes).
- Inclusive workplace promoting diversity and professional growth.
