Hybrid Drug Safety Physician – Pharmacovigilance

ICON; Mexico; Hybrid; MXN 600,000 - 900,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance

Retirement planning

LifeWorks EAP

Life assurance

Country-specific benefits

Job summary

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re looking for a Drug Safety Physician to provide medical and safety support to ICON Project Teams in Mexico, ensuring adherence to GCP and pharmacovigilance standards in a hybrid work setup.

The role involves reviewing adverse events, pharmacovigilance reporting, and providing input on Product Information and safety documentation, with emphasis on communication in English and collaboration with clients

Qualifications

• Qualified and licensed physician with 2-3 years of patient diagnosis and treatment experience.
• Experience in Clinical Research or Pharmacovigilance is a plus.
• Excellent English communication (oral, written and reading).
• University degree in medicine, science, or equivalent combination of education & experience.

Responsibilities

• Review coding and assess adverse events and adverse drug reactions for seriousness, expectedness, listedness and relatedness.
• Review aggregated reports to evaluate the product safety profile.
• Assess safety issues in trials or post-marketing settings and escalate with the client.
• Provide support in regulatory requirements for expedited and periodic AE/ADR reporting.
• Review and input Project Specific Procedures and participate in meetings.
• Communicate with the client as described in procedures.
• Assist in code-break activities.
• Input and consultancy to safety data sheets and product information.
• Provide pharmacovigilance consultancy to regulatory reporting requirements.
• Guide Staff on regulatory reporting of adverse events.
• Other responsibilities as assigned.

Skills

Excellent English communication

Regulatory knowledge

Clinical pharmacovigilance

Medical coding experience

Education

Medical degree

Tools

MedDRA

Job description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re looking for a Drug Safety Physician to provide medical and safety support to ICON Project Teams in Mexico, ensuring adherence to GCP and pharmacovigilance standards in a hybrid work setup.

The role involves reviewing adverse events, pharmacovigilance reporting, and providing input on Product Information and safety documentation, with emphasis on communication in English and collaboration with clients