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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Product Surveillance Specialist

Essential Functions

  • Capture, review and analyze product complaints.
  • Follow-up on customer usage reports and field service reports as necessary.
  • Comply with relevant global product quality related guidelines, standards and regulations regarding the receipt, review, investigation and reporting or product usage experiences.  This includes determining if complaints qualify as Medical Device Reports per Global Health Authorities regulations and guidance or if complaints potentially qualify as Vigilance reports per Global Health Authorities regulations.  it also includes evaluations of complaints for possible Adverse Events which are then forwarded to pharmacovigilance for review.
  • Collaborate with field service and manufacturing site personnel.
  • Review completed investigations for complaints and vigilance reports.
  • Collaborate with colleagues on reporting to regulatory bodies for imaging drug products and devices.
  • Conduct trend analyses in order to provide an alert to changing safety profiles on regular and adhoc basis.
  • Prepare and deliver accurate reports of continuing product performance for use within and outside of the department.
  • Identify potential product performance issues and alert appropriate management personnel when needed.
  • Work in conjunction and effectively communicate with various departments, including Legal Affairs, Regulatory Affairs, R&D, Manufacturing, Marketing, Medical Affairs, Sales, and Customer Service.
  • Provide product performance expertise on cross-functional project teams as necessary. 
  • Expanding technical and clinical knowledge of current product porfolio and new products.
  • Provide support during audits and regulatory inspections.
  • Participate in networking events with internal customers.

Candidate Profile

  • Previous Regulatory Affairs, Quality Assurance experience in the Pharmaceutical and/or Medical Device industry is strongly preferred.
  • A minimum of 2 years practical experience in a relevant environment is required.
  • Experience interacting with regulatory agencies such as the FDA.
  • Quality Management Systems (QMS) experience preferred
  • Writing and Verbal skills necessary to effectively communicate technical information to others.
  • Comfortable and capable of using software programs (Word, Excel, PowerPoint) and a willingness to expand and increase these competencies.
  • Involvement with field actions for drugs and/or medical devices preferred.

Education

BA/BS Degree in life science, engineering, business or equivalent.