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Drug Safety Manager

046828_2

About the role

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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 Medical & Safety Services Department (MSS), our Drug Safety Managers ensure that projects within MSS run efficiently, accurately and in accordance with ICON standards, regulatory requirements and contractual obligations to sponsors.  They provide project management on projects and oversee drug safety and administrative staff as assigned.
 
Purpose of the Role
  • To keep senior management appraised of any potential or actual study/staffing issues and develop solutions for the same.
  • To project manage small to mid-size drug safety projects, including sponsor liaison, management of quality standards/timelines/budgets and development of safety plans, study specific procedures (SSPs) and workflows for clients.
  • To assist senior management with resourcing and business development activities, including attendance at bid defense meetings as requested. 
  • To ensure audit readiness and/or represent MSS at audits. 
  • To actively identify options for process improvement and develop/implement departmental training to develop supporting staff skills, encouraging growth and providing regular performance feedback.
 
Role Requirements
 
  • The successful candidate will have advanced, proven relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with thorough knowledge of global safety processes/regulations and medical terminology/coding systems as well as contract and proposal preparation/review.
  • Proven ability to lead study teams and manage/mentor staff.
  • The ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors and sponsors.  Must be fluent in written and verbal English with good communication skills and excellent computer skills.  Detail orientated and capable of working effectively within a team environment.
  • Medical/science background (nursing preferred) 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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