Roche

Safety Data Transformation Lead / Specialist

Company
Roche
Location
Welwyn
Salary
Competitive
Posted
02 Mar 2021
Closes
15 Mar 2021
Ref
202102-104863
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Safety Data and ICSR Professional (two positions Lead and Specialist), within the Safety Operations Data Transformation team

Our team is here to use our pharmacovigilance expertise, particularly individual case safety report (ICSR) knowledge, 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.

We focus on mindset, where we want you to see beyond a job title and consider where you can have the biggest impact on patient safety. 

We need our people to have/be:
  • Profound knowledge of assigned topics and regulations within ICSR case processing, & strong broad knowledge across the end to end ICSR process in line with the expectations of the key stakeholders
  • Accountable leader, who role models proactive , self-motivated process development and issue management
  • 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 BPO/GPO network where necessary
  • Effective oversight of service providers via relationship management, and metrics and analysis.
  • Highly skilled at communicating expertise in a rational and structured approach to influence 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
  • Self-motivated to learn about new data sources, new regulations, and seek to co-create new solutions when required e.g. learning about novel artificial intelligence tools to develop new approaches with 'humans in the loop'
  • Effective leadership of complex initiatives with multiple stakeholders, with the ability to investigate and creatively solve problems and simplify, whilst meeting customer needs.
  • Team worker and coach , who acts on behalf of the whole company, and is open and supportive in co-located and virtual, matrix teams
  • Adaptable with the ability to handle ambiguity and continuously reprioritise to focus upon the most impactful work to our stakeholders and patients


Qualifications and experience:

  • Evidence of advanced learning e.g an undergraduate degree, however on-the-job pharmacovigilance experience would be equally considered.
  • Ideally the candidate would have demonstrated experience in a breadth of areas pertaining to pharmacovigilance, and pharmacovigilance legislation; good knowledge of international regulations (ICH, EU 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.
  • Safety Data Transformation Lead:  Evidence of leading complex, time-pressured projects, working with a wide range of stakeholders.
  • Safety Data Transformation Specialist:  Evidence of proactive, self-driven, independent working


 

Flexible working arrangements are encouraged so each person can fulfill 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.

Good luck with your application!

 

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