Drug Safety Physician
About the role
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- Medical review of assigned cases to include: 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
- 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 use of Clinical Trial Protocols, Product Information, Company Core Data Sheet and any other product related information needed in the course of assigned project
- 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
- Potentially, 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
- Travel (approximately 5%) domestic and/or international
- Other responsibilities as assigned.
- Medical Degree from an accredited institution of Medical Education (MD or DO)
- A minimum of 1 or more years of clinical research or industry experience
- Safety Database experience preferred
- Excellent computer skills; MS Excel and MS Access skills preferred
Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employee’s location, the employee may be required to possess a valid Driver’s license.
Application process
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Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
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