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Clinical Safety Operations Manager

2 months ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Pharmiweb Full time
About the Role

We are seeking a highly skilled Clinical Safety Operations Manager to join our team at ICON Strategic Solutions. As a key member of our Global Drug Safety function, you will play a critical role in ensuring the safety of our clients' products and contributing to the success of our business.

Key Responsibilities
  • Develop and implement effective safety strategies for assigned processes and delivery of operational safety aspects.
  • Provide key expertise and guidance to Global Drug Safety functions and other functions within the company, as well as vendors for safety operational tasks.
  • Accountable for the development, optimization, implementation, and documentation of appropriate processes to ensure Pharmacovigilance compliance in the area of responsibility.
  • Define process KPls, implement, monitor, and communicate performance and develop solutions for continuous improvements.
  • Ensure sponsor required compliance by vendors involved in clinical trials and non-interventional post-authorization studies in close collaboration with the Vendor Manager.
Requirements
  • Health Care Professional with extensive work experience in pharmacovigilance area, clinical development, project management, IT Systems.
  • Fluent in written and spoken English.
  • University degree is an advantage or relevant professional experience equal to scientific studies.
  • Proven project and process management skills.
  • Several years of professional experience (5-7 years) in Drug Safety/Clinical Trial Safety Management.
What We Offer

At ICON, we offer a competitive salary and a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a Global Employee Assistance Programme.

We are an equal opportunity and inclusive employer and are committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.