Drug Safety Physician - Mexico - Hybrid
ICON is a integral 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

📌 Drug Safety Physician (Ciudad de México)
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📍 Ciudad de México