Drug Safety Physician

About the role

ICON, a global healthcare intelligence and clinical research organisation, is looking for a Drug Safety Physician in Mexico City (hybrid) to provide medical and safety support to its Project Teams. The role ensures projects follow the highest ethical principles and medical standards, in line with GCP, good pharmacovigilance practices and applicable laws and regulations.

Key responsibilities

• Review coding (e.g. MedDRA) and accurately assess the seriousness, expectedness, listedness and relatedness of adverse events and adverse drug reactions
• Review aggregated reports such as patient profiles, line listings, IND annual reports, Annual Safety Reports and Periodic Safety Update Reports to assess the product safety profile
• Assess safety issues arising in clinical trials or post-marketing, escalate them to the line manager and agree a resolution approach with the client
• Support and train staff on regulatory requirements for expedited and periodic reporting of AEs/ADRs from clinical trials, post-authorisation studies, spontaneous reporting and literature
• Contribute to Project Specific Procedures, attend project meetings, communicate with the client as described in the procedures, and help prepare and run code-break activities
• Review and contribute to Product Information, Company Core Data Sheets and other product-related information, and give pharmacovigilance consultancy on regulatory reporting
• Advise Medical and Safety Services staff on regulatory reporting of adverse events

Required profile

• Licensed physician with 2-3 years of patient diagnosis and treatment experience in a hospital-based setting
• Prior experience in clinical research or pharmacovigilance (nice to have)
• Excellent oral, written and reading English
• University degree in medicine, science or an equivalent combination of education and experience
• Legal right to work in the country where the role is based

What we offer

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable
• Retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes and learning and development opportunities