Drug Safety Physician

Drug Safety Physician - Mexico - Hybrid

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We are looking for a Drug Safety Physician to provide medical and safety support to the activities of ICON Project Teams in order to ensure that projects are conducted according to the highest ethical principles and medical standards, in accordance with GCP and good pharmacovigilance practices and in compliance with applicable legal and regulatory standards

What you will be doing:

• Review of coding (e.g. MedDRA) and accurate assessment (seriousness, expectedness, listedness, relatedness) of Adverse Events (serious and non-serious) and of Adverse Drug Reactions (serious and non-serious)

• Review of aggregated reports (e.g. patient profiles, line listings, IND annual reports, Annual Safety Reports, Periodic Safety Update Reports) in terms of Product safety profile

• Provide assessment of safety issues arising in clinical trials or in the post-marketing setting and escalate those to the line manager within ICON and discuss the agreed approach on resolution with the client

• Provide support/training in all aspects of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorization studies, spontaneous reporting and literature

• Review and provide input to the Project Specific Procedures and participate in project related meetings

• Communicate with the client to an extent as described in the Project Specific Procedures

• Provide assistance in the preparation and conduct of code-break activities

• Review, assess and provide input to Product Information, Company Core Data Sheet and any other product related information as required by the client in the course of assigned project

• Provide input and consultancy to the client in the course of generation of the Company Core Data Sheet/Core Safety Information and Product Information

• Provide pharmacovigilance consultancy to the client in terms of regulatory requirements for expedited and periodic reporting of AEs/ADRs originating from clinical trials, post-authorization studies, spontaneous reporting and literature

• Provide guidance to Medical and Safety Services staff with regard to the regulatory reporting of adverse events

• Other responsibilities as assigned

Your Profile:

• Qualified and licensed physician with 2-3 years of patient diagnosis and treatment experience in a hospital-based setup.

• Prior experience in Clinical Research or Pharmacovigilance (Nice to have)

• Excellent communication in English (Oral, written and reading)

• University degree in medicine, science, and equivalent combination of education & experience

#LI-FP1

#LI-Hybrid

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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 wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply