Safety Lead - US, UK or Belgium

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Date: Jun 13, 2019

Location: 0, GB

Safety Lead - US, UK or Belgium
Help us transform patients’ lives
About UCB

 

At UCB, we put our heart, soul and skills into making a difference for people living with chronic disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

To strengthen our Global Patient Safety Group, we are looking to fill the positions of: 
Safety Lead – Early Clinical Development
Safety Lead – Immunology
Safety Lead – Neurology

 

What We Offer
An opportunity to:
•    Develop therapies in diseases with significant morbidity and unmet medical need 
•    To work in a space where the science is exciting and UCB is leading the innovation
•    To work on innovative products at all stages of product lifecycle
•    Demonstrate and hone strategic leadership skills in complex and critical situations concerning safety, risk management and pharmacovigilance. Provide strategic advice and guidance based on expertise and thorough understanding of business implications
•    Contribute to the development and implementation of innovative approaches to safety risk management and safety differentiation
•    An environment that encourages personal and professional growth through collaboration, sharing best practices and lessons learned
•    Be recognised as an expert on assigned product areas within the organization. 
•    Showcase your approach to building an inter departmental safety sub team and, teamwork and developmental skills of subordinates both direct and indirect 
•    Develop and practice state of the art safety risk management strategies to ensure the safe use of UCB products
•    Competitive salary and benefits including long term incentives

 

About the Role
You will be responsible for:
•    Global oversight of safety risk management activities for assigned product(s) including clinical safety, signal detection, signal management, aggregate reports, risk communication, risk mitigation and risk management
•    Accountability to lead, in a matrix structure, a cross-functional Benefit Risk Team (BRT). You will lead the development and maintenance of benefit risk assessments, safety risk management strategies and safety signal detection and assessment activities for assigned products. 
•    Providing strategic safety leadership for assigned product(s) across various cross-functional teams (e.g. life-cycle product team, labelling team) and governance bodies (e.g. Benefit Risk Board, Global Labelling Committee)
•    Collaborating with stakeholders within UCB (e.g. local safety officers, QPPV, clinical development) and outside of UCB (e.g. Key Opinion Leaders and regulators) to ensure the safe use of UCB products

 

About You
You should have:
•    An MD/PhD/PharmD qualification or the equivalent
•    Substantial experience within the pharmaceutical industry as well as a proven track record in scientific and project team leadership. Along with a good understanding of the global pharmacovigilance and safety requirements for non-clinical development, the registration process and onto the market
•    Strong personal leadership and communication skills and the ability to lead a multifunctional team
•    Strong scientific and analytic skills with an ability to provide interpretation and an assessment of complex data 
•    An understanding of how to translate non- clinical data to assess relevance in the clinical setting
•    Good knowledge of relevant regulations and proven evidence of effective delivery of high quality documents as well as relevant concepts in data management and systems, epidemiology and statistics
•    Ability to act without oversight in most circumstances as well as provide key input to difficult or sensitive projects
•    The ability to identify risks and propose corrective actions in complex and critical situations 
•    The technical skills and capabilities to author and contribute to large complex documents within document management systems and the knowledge of relevant concepts in health care, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance, drug development and statistics
•    Expertise in pharmacovigilance activities; pre-approval as well as post approval in addition to the relevant legislations and guidelines


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

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