Job Title: Senior Drug Safety Physician
Location: Chennai, Trivandrum
Company: ICON plc
Job ID: JR130253
Work Type: Office-Based
About the Role:
As a Senior Drug Safety Physician, you will play a vital role in ensuring that ICON’s clinical research projects are conducted with the highest medical, ethical, and regulatory standards. You will provide pharmacovigilance expertise and medical support across clinical and post-marketing settings, ensuring drug safety through proactive review, analysis, and consultation with project teams and clients.
Key Responsibilities:
Review and assess Adverse Events (AEs) and Adverse Drug Reactions (ADRs) for seriousness, expectedness, relatedness, and accuracy of coding (e.g., MedDRA).
Evaluate aggregated safety reports (e.g., line listings, patient profiles, IND Annual Reports, PSURs).
Provide safety assessments during clinical trials and post-marketing surveillance and escalate safety concerns when necessary.
Support and train teams on AE/ADR regulatory reporting in clinical trials, spontaneous reporting, literature surveillance, and post-authorization studies.
Contribute to Project Specific Procedures and participate in related meetings.
Assist in code-break activities and provide input on product-related documents such as Company Core Data Sheets.
Offer regulatory and pharmacovigilance consultancy to clients and guide teams on safety reporting requirements.
Role Requirements:
Qualified and licensed physician.
2–5 years of clinical experience in a hospital-based setting (diagnosis and treatment).
2–3 years of prior experience in pharmacovigilance or clinical research.
Benefits at ICON:
Competitive salary and annual performance-based bonuses.
Comprehensive health benefits for you and your family.
Retirement plans and life assurance coverage.
Global Employee Assistance Programme (LifeWorks) offering 24/7 support.
Optional benefits tailored to local needs such as gym memberships, subsidized travel, and childcare support.
Inclusive and diverse work culture with a strong focus on equality and accessibility.
Important Notes:
This is an office-based role, not remote.
If you require accommodations during the application process due to a medical condition or disability, ICON encourages you to request support.
Even if you do not meet every requirement, you're encouraged to apply—ICON values diverse talent.
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