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Safety Specialist

Website Achieva Group Limited

6 Months – Outside IR35. Office, hybrid, fully remote working all considered. 

Safety Medical Device Specialist within the Safety Operations 

Our team is here to use our safety and vigilance expertise, to ensure safety data is processed and reported in a high quality, compliant manner, so it can be used to understand and communicate the product benefit risk to protect patients’ safety.

The jobholder is primarily responsible for oversight of the processing and reporting of device related safety incidents at our service provider via the utilisation of current/future safety systems, and partners to ensure that the quality/usability of AEs and other safety report outputs conforms with agreed customer requirements 

Qualifications and experience:

  • Evidence of advanced learning e.g., an undergraduate degree, however on-the-job safety and vigilance experience would be equally considered.
  • Significant depth and breath of Medical Device safety and incident reporting, ideally in both pre-and post-marketing setting
  • Ideally the candidate would have demonstrated experience and knowledge in a breadth of areas pertaining to pharmacovigilance and medical device legislation; good knowledge of international regulations (ICH, EU MDR & IVDR, GVP Modules, FDA) and an understanding of the pharmaceutical industry (product development and the commercial environment) and of rapidly evolving personalised healthcare environment and ecosystem.
  • Evidence of leading complex, time-pressured projects, working with a wide range of stakeholders.

Once the Roche MD process is in place, daily tasks of the role include:

  • Performing oversight of service provider who execute expedited reporting tasks
  • Acting as a point of contact/ representative for the Medical Devices data transformation pre and post marketing processes and sharing your subject matter expertise to stakeholders (at the service provider, business partners, auditors, and inspectors)
  • Conducting process reviews to design and implement process improvements
  • Identifying root causes of non-compliance to agree Corrective Actions and Preventive Actions (CAPAs), which you may be responsible for implementing
  • Impact assessment of new / updated regulatory requirements upon your topic 
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