At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

As a Senior Drug Safety Associate you will be managing individual case reports (Serious Adverse Events, Adverse Drug Reactions), reconciliation of SAEs, coding and data retrievals from the safety database, supporting the generation of periodic safety reports, and DSMB/DMC reviews. Within this role, your responsibilities will include, but are not limited to:

• Producing concise and accurate narratives
  
• Performing coding of diseases, adverse events and medications
  
• Submission of safety reports to the relevant authorities
  
• Processing individual case safety reports
  
• Reconciliation of Serious Adverse Events
  
• Generating data listings from the safety database
  
• Complete first-line review of drafted Safety Management plans
  
• Provide technical and process oversight with respect to safety services
  
• Coach and mentor less experienced drug safety associates
  
• Serve as Lead Drug Safety Associate and coordinate global teams of drug safety associates
  
• Reports project status (including monthly metrics) to project/functional management within agreed upon timelines
  
• Quality control less experienced colleagues data entry, narrative writing and queries
  
• Quality control the reportability assessment of ICSRs
  
• Participate in internal and client project team meetings, including presentation of the safety process at kick-off and investigator meetings
  
• Ensure consistency of plans with client contract and identifies out of scope activities promptly and accurately.
  
• Propose solutions for procedural and technical issues.
  
• Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.
  

You are...

• Degree Educated in a life sciences or related field
  
• Relevant experience within PV or Drug Safety including leading projects or acting as a Senior member of the team with project delivery.
  
• Previous Audit or CAPA experience would be advantageous
  
• Organised with a good attention to detail
  
• Able to work on multiple projects and demanding deadlines
  
• Experienced with Microsoft Office
  

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

Are you a current ICON Employee? Please click here to apply: link