Drug Safety Physician

About the role

We are seeking a Drug Safety Physician to join ICON plc’s clinical research teams in Mexico. The role supports project safety activities, ensuring compliance with ethical standards, GCP and pharmacovigilance regulations.

Key responsibilities

• Review coding (e.g., MedDRA) and assess seriousness, expectedness, listedness, and relatedness of adverse events and drug reactions.
• Evaluate aggregated safety reports such as patient profiles, line listings, IND annual reports, and periodic safety update reports.
• Provide safety issue assessments for clinical trials and post‑marketing settings, escalating to line manager and discussing resolutions with the client.
• Support and train teams on regulatory requirements for expedited and periodic reporting of AEs/ADRs from trials, post‑authorization studies, spontaneous reports, and literature.
• Contribute to project‑specific procedures, attend project meetings, and communicate with the client as defined.
• Assist in code‑break activities, review product information, and provide consultancy on core safety data sheets.
• Guide medical and safety staff on regulatory adverse event reporting.

Required profile

• Qualified and licensed physician with 2‑3 years of patient diagnosis and treatment experience in a hospital setting.
• Prior experience in clinical research or pharmacovigilance is a plus.
• Excellent written and spoken English.
• University degree in medicine or related scientific field.

Required skills

• MedDRA coding and adverse event assessment.
• Good Clinical Practice (GCP) knowledge.
• Pharmacovigilance processes and regulatory reporting.

What we offer

• Inclusive environment that rewards high performance.
• Opportunities to work on innovative clinical development projects.
• Hybrid work mode supporting work‑life balance.