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Drug Safety Associate

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About the role

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Senior Drug Safety Associate
 
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. The Senior Drug Safety Associate will perform processing for all types of safety events, and other medically-related project information.  Serve as pharmacovigilance (PV) lead for projects providing project management support, ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information and assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.
 
Overview of the Role
  • Complete  all  departmental  project  activities  accurately  in  accordance  with  ICON  SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes.
  • Review and process safety events (pre-marketing,  post-marketing,  device and drug) and/or other medically related information per assigned tasks and project specific procedures.
  • Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files.
  • Perform safety review of clinical and diagnostic data as part of case processing.
  • Generation of project specific procedures
  • Act as Pharmacovigilance lead for regional projects, or assist as needed with global projects
  • Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER.
  • Support QPPV as required.
  • Support development of clinical trial activities such as DSURs, 6-monthly line listings, by liaising with other ICON departments and/or other Sponsor vendors
  • Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues.
  • Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate.
  • Assist with identifying out of scope activities in conjunction with the PV Project lead (as applicable).
  • Actively identify out of scope activities
  • Attend project team and Sponsor meetings (including Investigator meetings) and teleconferences as required.
  • Train/Mentor Drug Safety Associate staff
  • Participation in interdepartmental activities (e.g. quality control processes, quality assurance (audits), miscellaneous project activities)
  • Assist management with weekly and monthly project status reports including quality review findings and metrics
  • Assist with development and conduct of safety presentation for start-up meetings, Investigator meetings and other meetings
  • Perform other activities as identified and requested by management.
Role Requirements
  • You will possess a minimum of 2 year pharmacovigilance experience or other equivalent clinical or pharmaceutical experience along with a RN,  Bachelor’s in Nursing, , or RPH or PharmD,  or equivalent experience as a licensed healthcare professional.
  • Knowledge of medical terminology and coding systems
  • Basic computer skills (Microsoft Word, Excel, Outlook, Access)
  • Good communication skills
  • Detail oriented
  • Fluent in written and verbal English
  • Work effectively within a team environment
 
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 - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
 
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