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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

 

Pharmacovigilance (PV) Specialist

Job Description

 

Pharmacovigilance (PV)

  • Collecting, assessing, performing and document the local quality control safety reports, transmitting them with a copy of the source documents to the HQ PV, and report to local HA following applicable procedure and regulations,
  • Acting at the interface between the HQ PV and the reporters or the local Competent Authorities by relaying any question, answer or comment
  • Applying locally the HQ PV quality documents in force (procedures, instructions, standard forms),
  • Organizing the continuity of PV activities at local level, with the designation and training of an LRPPV back-up,


Quality Management System 

  • Ensure that a local quality management system is established, implemented and maintained, aligning with global standard operating procedures and instructions, local regulation and law, as well as accreditation that the affiliate upholds.
  • Ensure local procedures are in place to ensure (not limited to) the handling and management of trainings, quality risk, documentation, vendor certification and monitoring, complaint, return, reject, recall, falsification, self-inspection, local supplementary labeling/packaging (if required) are performed effectively and in a timely manner in accordance with global SOP as well as local regulation and law.

 

Vendor management 

  • Be the quality contact person dealing with subcontractors including TPLs in Australia and New Zealand, of which the services and/or products have impact to GDP, patient safety and/or product quality


Routine GXP operation

  • Carry out necessary steps to facilitate accurate and timely quality decision for GDP release of inbound goods arriving at TPL in Australia and New Zealand

 

Regulatory 

  • Prepare and submit regulatory applications for responsible projects to health authorities according to planned/ targeted timeline.
  • Monitor routinely government legislation changes and implement necessary changes to the business in a timely manner. 

Required Skills & Background

​​​​​​​

  • Pharmacist required 
  • 1 -3 years’ experience in pharmaceutical company ( PV experience preferred)
  • Proficient in MS Office, including Word, Excel and PowerPoint
  • Proficient verbal and written English skills 
  • Strong communication, analytical and systems skills.
  • Attention to detail and ability to multi-task
  • Work systematically according to regulations
  • High responsibility on duties

Reasons to join us

 

Much more than a Competitive salary, we offer continued personal development. When you join Guerbet, you:

  • Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
  • Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
  • Are joining a company where we value diversity of talents coming from various horizons.

 

We # Innovate # Cooperate # Care #Achieve at Guerbet.