Drug Safety Physician
About the role
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- 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
- 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 and use of Clinical Trial Protocols, Product Information, Company Core Data Sheet and any other product related information needed in the course of assigned project
- Medical Degree from an accredited institution of Medical education
- The successful candidate will ideally have 1 or more years of clinical research or industry experience.
- You will have excellent verbal and written communication (English and local language) combined with excellent computer skills; Excel and Access skills preferred and basic presentation skills
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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