Drug Safety Physician
ICON · Chennai, India +1 more
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Role summary
A Drug Safety Physician will evaluate adverse events and drug reactions in clinical trials and post-marketing settings, ensuring compliance with regulatory and ethical standards. Responsibilities include coding and assessing safety data, reviewing aggregated reports, providing pharmacovigilance consultancy, and supporting expedited and periodic reporting requirements. The role requires a licensed physician with 2–3 years of relevant experience.
What they're looking for
- Licensed physician with medical degree
- 2-3 years patient diagnosis and treatment experience in hospital setting
- Clinical research or pharmacovigilance experience preferred
- Knowledge of adverse event coding and assessment methodologies
- Understanding of GCP guidelines and pharmacovigilance regulations
- Familiarity with regulatory reporting requirements for drug safety
What you'll be doing
- Review and assess adverse events using MedDRA coding for seriousness and relatedness
- Evaluate aggregated safety reports and patient profiles for product safety assessment
- Identify and escalate safety issues from clinical trials or post-marketing settings
- Provide training on regulatory requirements for expedited and periodic adverse event reporting
- Review product information and core safety data sheets with client input
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.