Safety Specialist Job in United Kingdom. Apply for the latest United Kingdom jobs in Medical/Pharmaceutical/Scientific in , , United Kingdom.
Safety Specialist Job in United Kingdom
Job Description
An excellent opportunity has arisen for an experienced Safety Medical Device Specialist to join my client on an initial 6 month contract basis.
The role is outside of IR35 and the pay rate is up to £45.00 per hour.
Your primary focus within this role will be to oversee the processing and reporting of device related safety incidents at my clients service provider, via the utilisation of current/future safety systems, ensuring that the quality/usability of AEs and other safety report outputs conforms with agreed customer requirements.
Required Experience:
Profound knowledge and expertise for medical device reporting processes, partnering with other safety functions to meet both current and future requirements for a variety of safety related data outputs and HA communications
Accountable leader, who role models proactive, self-motivated process development and issue management and supports the development, maintenance, and review of metrics and KPIs to identify opportunities for continuous improvement
Quality mindset, maintains procedural documents and training, devises strategies and solutions to contain issues, mitigate risks and develop solutions, is transparent with risks identified and escalates to safety network where necessary.
Effective oversight of service providers via relationship management, metrics and analysis. Monitors workload, compliance, and quality across the medical device data global footprint to ensure internal and external performance standards are maintained
Highly skilled at communicating expertise in a rational and structured approach to upskill colleagues, and to articulate the process and approach to external stakeholders e.g., during regulatory inspections
Independent decision-maker, making compliant and pragmatic decisions based on seeing
Critical thinker who can see the bigger picture in order to connect processes, data, ideas, and people. Sustaining effective partnerships with key stakeholders across Safety functions and the wider company organisation to ensure success of Operations related activities.
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.
Responsibilities 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 (within the company, 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
Flexible working arrangements are encouraged so each person can fulfil the needs of their job role, look after their own wellbeing, and support their colleagues. We are open to location flexibility within the UK, so we encourage you not to let location define your decision to apply.
For further details, please contact Lewis Coulson on (phone number removed) or email (url removed)
Location: United Kingdom
Category: Medical/Pharmaceutical/Scientific
Job Title: Safety Specialist
Salary: £30 – £45/hour
Benefits: Full Time
Job Type: Contract, Full Time
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