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Safety Medical Device Specialist

2 weeks ago

Welwyn Garden City, United Kingdom CK GROUP Full time

CK Group are recruiting for a Safety Medical Device Specialist to join a pharmaceutical company in a Remote Based role on an initial 6-month contract basis. Role Outside IR35.
**The Role**:
The main purpose of the role will be 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.
- Oversee the processing and reporting of device related safety incidents at service providers via the utilisation of current/future safety systems to ensure that the quality/usability of AEs and other safety report outputs conforms with agreed requirements
- Maintain procedural documents and training, devise strategies and solutions to contain issues, mitigate risks and develop solutions

**Further responsibilities will include**:

- Monitoring workload, compliance, and quality across the medical device data global footprint to ensure internal and external performance standards are maintained
- Sustaining effective partnerships with key stakeholders across Safety functions and the wider organisation to ensure success of Operations related activities
- Developing and maintaining knowledge of the use of relevant new methods and technologies, such as artificial intelligence for safety data processing.

**Your Background**:
To succeed in this role, you will come from a Life Science background with on-the-job safety and vigilance experience
- Significant depth and breadth of Medical Device safety and incident reporting, ideally in both pre-and post-marketing setting
- Experience and knowledge in a breadth of areas pertaining to pharmacovigilance and medical device legislation; (ICH, EU MDR & IVDR, GVP Modules, FDA) and an understanding of product development and the commercial environment, and of rapidly evolving personalisedhealthcare environment and ecosystem.

**A pply:
**It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53999 in all correspondence.

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference xxxxx in all correspondence.