Loading...
Share this Job
Apply now »

 

Let's push the boundaries together and make the most of your talents!

Safety Lead - Mature Products

Location: 

Slough, Berkshire, United Kingdom

Job Function:  Drug Safety & Pharmacovigilance
Job ID:  65791

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe 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?

Safety Lead – Mature Products
Help us transform patients’ lives
UK or Belgium

 

To strengthen our Global Patient Safety Group, we are looking to fill the position of: Safety Lead – Mature Products

 

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). Ensure that all relevant emerging data are assessed, acted upon, and integrated into the benefit risk assessment in a timely manner
•    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
•    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
•    The ability to understand science and biology and understand the significance of preclinical findings when planning use in man. Act without oversight in most circumstances as well as provide key input to difficult or sensitive projects
•    Be able to identify risks and propose corrective actions in complex and critical situations and the ability to a multifunctional team as well basic project management skills to allow management and delivery of multiple complex deliverables within tight timelines
•    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
•    Have expertise and good knowledge of all  phases from FIM to post approval and relevant legislations and guidelines

 

What We Offer
An opportunity to:
•    Lead 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 responsible product areas within the organization. And Provide expertise and input to life-cycle product teams
•    Showcase your approach to building an inter departmental safety sub team, 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 us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 


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

Apply now »