Drug Safety Physician

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 currently seeking a Drug Safety Physician to join our diverse and dynamic team. As a Drug Safety Physician at ICON, you will play a pivotal role in overseeing the medical aspects of pharmacovigilance activities, ensuring the safety of investigational drugs and contributing to the advancement of inNvative treatments and therapies.

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)
• Provide support to the Drug Information & Pharmacovigilance Product Support (call) Centre and
• the related projects, including provision of the Product related information to the callers as well as review and assessment of reported adverse reactions
• 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 authorisation 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, asses and provide input to Clinical Trial Protocols, 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-authorisation studies, spontaneous reporting and literature
• Provide guidance to Medical and Safety Services staff with regards to the regulatory reporting of adverse event
• Other responsibilities as assigned.

Your profile

• Medical degree (MD or equivalent) with active medical license.

• Board certification or equivalent experience in a relevant medical specialty (e.g., internal medicine, pharmacology).

• Previous experience in pharmacovigilance or drug safety within the pharmaceutical or biotechNlogy industry preferred.

• Strong clinical judgment and analytical skills, with the ability to interpret complex medical data and make informed decisions.

• Excellent communication and collaboration skills, with the ability to work effectively within a multidisciplinary team environment.

What ICON can offer you:

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.

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