Drug Safety Physician

ICON; Ciudad de México; Presencial; MXN 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave entitlements

Health insurance

Retirement planning

LifeWorks EAP

Life assurance

Country-specific benefits

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Excellent English communication

Regulatory knowledge

Clinical pharmacovigilance

Medical coding experience

Educación

Medical degree

Herramientas

MedDRA

Descripción del empleo

Drug Safety Physician - Mexico - Hybrid

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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 elevate 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

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here