My client is a Global pharmaceutical company, and they have a position available for a Pharmacovigilance/ Safety Medical Device Specialist to join their Safety Operations team for an initial 6-month contract.
The Safety Operations team use their 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.
As the Pharmacovigilance / Safety Medical device consultant you will be accountable for delivering the strategy for the transformation and delivery of medical device safety data in order to meet both current and future requirements for a variety of safety related data outputs.
You will will play a key role in the design and implementation of medical device processes and will be accountable and responsible for training and upskilling for the rest of the organisation. You will be 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 (e.g., regulatory compliance requirements; and/or internal scientific data requirements).
Daily tasks 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
- 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
Education, Experience and Skills:
- Scientific degree
- Significant depth and breadth of Medical Device safety and incident reporting, ideally in both pre-and post-marketing setting
- 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.
Before you apply for this position it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and be based in the UK.
To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on 0203 465 0045. #4242612