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Senior Drug Safety Associate - Safety Reporting

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About the role

This vacancy has now expired. Please see similar roles below...

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.  As part of our Safety Reporting Group in ICON’s Global Regulatory Affairs Department, our DSA’s contribute to our culture of process improvement, perform expedited and periodic safety reporting, maintain projects and liaise with Sponsors, ICON project managers and investigational sites as required.  
 
Purpose of the Role
  • As a Snr DSA, you will be expected to prepare regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, Principal Investigators and business partners.
  • Ensure compliance with regulatory reporting requirements for safety reporting in clinical trials.
  • Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information.
  • Ensure the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors.
Role Requirements
  • The successful candidate will have relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems. 
  • Must be fluent in written and verbal English with good communication skills and basic computer skills.  Detail orientated and capable of working effectively within a team environment. 
  • Medical/science background and/or bachelor’s degree or local equivalent.
Benefits
 
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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