Senior Manager, Drug Safety

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.

Are you interested in serving as the client’s main point of contact for the entire life-cycle stand alone projects, and be the main safety reporting point of contact?

The role:
The Drug Safety Manager within SRG is responsible for completing projects successfully on-time, within budget, and with approved quality levels and support achievement of the department’s overall financial and quality goals and objectives.
• The Drug Safety Manager will oversee the implementation of projects, including client communications, project specific plans, system set-up, and establishment of appropriate and agreed-upon metrics.
• Lead identification of out-of-scope activities and process efficiency/improvement needs and implement contract amendments/change orders.
• The DSM will also ensure completion of project status reports/review meetings, including burn hours, profit margins, quality review findings, and other metrics.

Attractive points:

• Gain experience in a wide range of therapeutic areas including drug and device safety in a global working environment, interacting with business leaders from different departments, and senior leadership.
• Oversee clinical safety case management and aggregate reporting responsibilities of line reports – specialized in both clinical trial and post-marketing safety management.
• As primary contact for safety in Japan (In-country Clinical Caretaker), the role offers opportunities to collaborate with global top 20 biopharma.
• Independently lead initiatives in Japan and represent the department in audits/inspections, leadership meetings, and business development activities.
• As core member of leadership team, involve in key decision making within the department.
• Role offers opportunity to develop into a director leading multiple safety teams in different countries.
• Competitive salary advantage.
• Flexible working schedule (Remote/home-based).

• You will need:
  • Medical/science background (nursing preferred) and/or bachelor’s degree or local equivalent.
  • Minimum of 5 years related experience in Pharmacovigilance/Clinical Research.
  • To be successful you will be expected to be proficient in Microsoft Office skills (Word, Excel, and Access) and advanced safety database proficiency.
  • Have good communication skills, be fluent in written and verbal English, detail-oriented and have the ability to work effectively within a team environment.
  
  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.

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