Associate Director, Patient Safety Scientist (RTP/Slough/Brussels)
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POST DATE 8/26/2016
END DATE 10/14/2016
JOB DESCRIPTIONWe all share one big ambition. What s yours?
Everyone who works at UCB 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 UCB 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.
To help us meet our ambitions and provide the best solutions to patients, UCB is currently seeking a talented individual as Associate Director, Patient Safety Scientist based in one of our locations in the US, UK or Belgium.
Incumbent has responsibility for input into the safety management of assigned products, which includes signal detection, signal assessment, benefit risk evaluation, analysis of individual cases, preparation of aggregate reports, input into safety risk management deliverables, and responding to requests from health authorities. Review of UCB deliverables is also part of the responsibilities. He/she will work on tasks assigned by his/her manager and by the safety lead (SL) or equivalent for the product(s) which can include some or all of the above as well as working with the Patient Value Units (PVUs) on specific missions, clinical trials or submissions. The Patient Safety Scientist may be required to work on multiple products at various lifecycle stages, depending upon the needs of Patient Safety (PS).
* Be one of the safety experts for assigned products
* Work under minimal supervision on routine tasks
* Work on more complex processes, systems, projects and issues with supervision
* Identify risks and propose corrective actions in moderately complex situations
* Apply appropriate strategies and option based rationale
* Apply best practices, principles and theories in moderately complex situations and issues
* Coordinate work with manager and Safety Lead for assigned products
* May provide training to project teams or at project related external meetings on medical issues or pharmacovigilance
* Provide scientific input in signal detection, strategy and evaluation
* Write and review, and when applicable, approve response to questions from competent Authorities
* Liaise with local safety officers (LSOs) and other affiliated personnel on responses to local authorities
* When applicable, be responsible for risk-benefit assessment for assigned products
* Communicate without delay with SL if safety issues are identified Reviews of appropriate data from product complaints database for patient safety implications
* Fulfill required responsibilities of project team member and when delegated as project team leader (as determined by project governance: may participate in study team)
* When applicable, provide safety input and review to aggregate reports and ad hoc safety reports
* When applicable provides input into pharmacovigilance process improvement (eg, assigned member of process workstreams)
* When applicable, provide input to safety operations
* Review and provide safety input for relevant clinical or regulatory documents for assigned products (IB, protocols, RMP, SmPC, US PI, PIL, EMA article 31s, FDA field alerts , and OSS/Recall Medical Assessments, etc)
* Provide support to SL, Benefit Risk Team (BRT) for Global Labelling Committee (GLC), Benefit Risk Board (BRB), and PVU activities
* Produce accurate and fit-for-purpose signal evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data,
* Lead ad hoc pharmacovigilance projects
* If not a Physician, ability to know appropriate times to get medical input and review and to develop working relationship with other Patient Safety team members who are physicians
* PharmD, DVM required, PhD degree preferred or other relevant advanced degree
* 5+ years relevant industry experience
* 3+ years experience within safety/PV
* Strong scientific/medical background
* Innovative problem solving skills
* Understands business and cultural drivers
* Skilled at operating in cross- cultural team environment
* Able to identify and resolve issues related to performance and/or understanding and can effectively deal with conflict/disagreement
* Able to give presentations to interdepartmental audiences
* Ability to act as a company representative (e.g. regulatory inspectors)
* Inspires confidence through influencing skills and technical ability
* Proven diagnostic/analytical/evaluation skills with strong attention to details
* Well organized, structured, with a logic approach to issues raised
* Flexible, able to cope with changing priorities, ability to handle uncertainty
* Excellent oral/written skills in English with a proven ability to write/edit scientific reports
* Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes
* Able to see underlying or hidden medical problems and proactively take actions
* Able to understand and analyze clinical and medical data
* Able to work independently and to solve complex problems and multiple projects
* Can manage uncertainty and risks
* Knowledge and understanding of applicable regulations in pharmacovigilance and clinical development
* Maintains knowledge of industry trends and best practices
* Ability to extrapolate from known knowledge into new situations
UCB 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, UCB 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 UCB.
UCB and its subsidiaries encourage diversity in the workplace; we are an Equal Opportunity Employer. Minority/Female/Disability/Veteran