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Senior Drug Safety Physician

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016155_2

About the role

This vacancy has now expired. Please click here to view live vacancies.
This is an exciting opportunity to work within the Medical & Safety Services department at ICON, a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.  As a Senior Drug Safety Physician, you will be involved in providing 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.
 
Overview of the Role
  • You will review the coding (eg. MedDRA) and accurate assessment (seriousness, expectedness, listedness, relatedness) of Adverse Events (serious and non-serious) and of Adverse Drug Reactions (serious and non-serious).  You will also review aggregated reports (e.g. patient profiles, line listings, IND annual reports, Annual Safety Reports, Periodic Safety Update Reports) in terms of Product safety profile.
  • You will 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 and also provide input and consultancy to the client on the same.
  • You will review and provide input to the Project Specific Procedures and participate in project related meetings, communicating with the client to the extent specified.
  • You will provide guidance to all Medical & Safety Services staff related to the regulatory reporting of adverse events.   
Role Requirements
  • You will have in-depth proven clinical research or industry experience.
  • You will be fluent in English with excellent verbal and written communication skills together with previous presentation experience.
  • You will require excellent computer skills, preferably with in-depth knowledge of Excel and Access in particular.
Benefits of Working in ICON
 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
 
We care about our people as they are the key to our success.  We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
 
What’s Next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer – M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

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