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Safety Lead (Physician) - United Kingdom  

Company managed [?] Still accepting applications

Posted on : 25 April 2017

Project Description

Description:
  • Everyone who works at our company  holds the same ambition – to transform the lives of people living with severe diseases. 
  • Of course we have other associated ambitions too - including a desire to support each other in attaining all of our own personal and professional goals. 
  • That’s why we ensure every company colleague has the tools and environment to engage effectively in the work we do. 
  • Wherever in the world we’re based, and whatever role we play, we believe each of us can have an impact across our organization. 

  
THE ORGANISATION 
  • Our company is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 8 600 people in approximately 40 countries, the company generated revenue of € 3.3 billion in 2014. 
  • Our company aspires to be the patient-centric biopharmaceutical leader transforming the lives of people living with severe diseases. 
  • Our company  is growing to become the next generation Bio pharma leader and need exceptional individuals to achieve this goal. 
  • We are looking for enthusiastic and talented professionals who thrive on challenge and change, and who want to make a difference and deliver results. 
  • Everyone who works at our company holds the same ambition – to transform the lives of people living with severe diseases.  
  • Of course we have other associated ambitions too - including a desire to support each other in attaining all of our own personal and professional goals. 
  • That’s why we ensure every company  colleague has the tools and environment to engage effectively in the work we do. 
  • Wherever in the world we’re based, and whatever role we play, we believe each of us can have an impact across our organization. 


  
THE POSITION
The product Safety Lead (SL) as chair/co-chair of the Benefit Risk Team is responsible for ensuring that the benefit risk assessment of the product is current and that changes to the assessment are followed by appropriate discussion and actions, per company's governance principles.   
  • Ensures patient safety for company  products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of PV Assessment activities through product development, product maintenance and life cycle management. 
  • responsible for representing at the Patient Solution Team (PST) or Value Unit (PVU) all activities related to Pharmacovigilance, clinical safety, risk management and signal detection, and for reporting back to the Patient Safety organization relevant information regarding status, issues, challenges etc. 
  • accountable to the PST/PVU to lead in a matrix structure the Benefit/Risk activities that ensure the timely signal detection, risk management/mitigation plans, safety analyses in aggregate reports and the scientific review of safety related information, ensuring the timeliness and accuracy of the safety information in responses to Health Authorities, product labelling and investigator brochures. 
  • ensure in depth knowledge of safety profile of assigned product 
  • Ensure adequate representation for all activities related to Pharmacovigilance, clinical safety, risk management and signal detection 
  • Ensure PST/PVU issues and challenges, including benefit/risk changes, are known by the Patient Safety organization 
  • Lead the effort within Patient Safety to ensure PST/PVU deliverables are met 
  • Ensure adequate representation of different functions (not limited to safety) are  identified  and contribute to the benefit risk assessment, Safety Risk Management Strategy (SRMS) and other safety driven documents in collaboration with the line managers 
  • Lead the cross functional effort within Patient Safety and when appropriate with outside contractors/vendors to ensure Patient Safety deliverables are met 
  • Ensure that the Benefit Risk Assessment, SRMS and other safety driven documents are current , aligned and that changes to the assessment are followed by appropriate actions to be proposed to the PST/PVU 
  • Lead interactions between the BRT and QPPV and BRB ensuring good communication that is both appropriate and timely 
  • Be accountable to the PST/PVU that PV regulatory reporting requirements are met 
  • Ensure that the Case Processing teams are aware of the project specific issues (product, disease or protocol related) 
  • Maintain knowledge of (or have access to knowledge if product is outsourced) safety profile of assigned product 
  • Ensure compliance with global regulations and ICH guidelines regarding the preparation of required regulatory expedited and periodic reports, in collaboration with other Patient Safety teams 
  • Preparation (as required), review, and approval of product safety information in all ad hoc documents, investigator brochure or regulatory-required periodic reports requiring medical review and interpretation, including providing medical opinion on all relevant documents prior to submission to regulatory authorities, journals and external documents prior to submission to regulatory authorities, journals and external meetings, and providing medical input to protocols and end-of-study reports. 
  • Lead scientists and physicians in the assessment and writing of medical sections in periodic reports, ad-hoc safety analyses, responses to regulatory authorities and clinical study documents. Review output 
  • Responsible for the combined (clinical study and post marketing sources) Safety Signal Detection process.  
  

In addition, the SL may be responsible/accountable for:   
  • Liaising with LSOs on responses to local authorities 
  • Reviewing and approving all aggregate reports for assigned products 
  • Reviewing and approving responses to questions from competent Authorities 
  • Facilitating the production and maintenance of RMPs and REMS 
  • Ensuring that designated RMP team members document the effectiveness of risk minimization activities, as described in the RMP. 
  • Ensuring timely reporting to Health Authorities on progress, execution and effectiveness of commitments as required by Health Authorities 
  • Analysing unlisted (unlabelled) serious and non-serious reactions  
  

PROFILE   
  • Medically qualified (essential) 
  • Significant pharmaceutical industry experience with a proven and successful track record in scientific and project team leadership. 
  • Understanding of the global Pharmacovigilance and safety requirements from non-clinical development through the registration process and onto the market. 
  • Preferably experience in early development products 
  • Preferably experience in neurology products 
  • Sound decision-making ability   
  • Good knowledge of Pharmacovigilance relevant regulations and company standards. 
  • Proven evidence of effective delivery of high quality documents 
  • Knowledge of relevant concepts in data management and systems, epidemiology and statistics 
  • Ability to understand novel science and biology and appreciate and understand the significance of preclinical findings when planning use in man 
  • Can act without oversight in most circumstances and is able to provide key input to difficult or sensitive projects 
  • Can identify risks and propose corrective actions in complex and critical situations 
  • Ability to lead a multifunctional team 
  • Basic project management skills to allow management and delivery of multiple complex deliverables within tight timelines 
  • The technical skills and capabilities to author/contribute to large complex documents within document management systems 
  • Effective Communicator 
  • Can lead and help teams and others to solve problems creatively and practically and to develop efficient processes or solutions 
  • Capable of leading and motivating an interdepartmental team 
  • Utilises colleagues’ skills effectively  
  


About us:
  • Our company  is a global biopharmaceutical company. 
  • We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people with severe diseases of the immune system – or the central nervous system. 
  • With more than 8500 people in approximately 40 countries, our company  offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive. 
  • Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at our company.

    
Job Segment:  Epidemiology, Neurology, Medical, Public Health, Pharmacovigilance, Healthcare