Associate Safety Lead

Apply now

Date: Jun 12, 2019

Location: Braine L'alleud, Walloon Brabant, BE

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?

Associate Safety Lead
UCB – Inspired by patients. Driven by science.
Help us transform patients’ lives.

 

To strengthen our Patient Safety Group, we are looking to fill the position of: Associate Safety Lead

 

About the Role
You will be responsible for:
•    Ensure PVU issues and challenges, including benefit/risk changes, are known by the Safety Lead 
•    Ensure that the Benefit Risk Assessment, SRMS and other safety driven documents for which responsibility is delegated by SL are current, aligned and that changes to the assessment are followed by appropriate actions to be proposed to PVU 
•    Facilitate good communication (with the SL) between the PVU/BRT and QPPV and BRB Maintain knowledge of (or have access to knowledge if product is outsourced) safety profile of assigned product 
•    Ensuring compliance with global regulations and ICH guidelines regarding the preparation of required regulatory expedited and periodic reports, in collaboration with Patient Safety operations 
•    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.
•    Responsibility with the SL for the combined (clinical study and post marketing sources) Safety Signal Detection process. 
•    Lead cross functional teams 
•    Communicate openly and positively with team members to ensure alignment of functions in the Benefit Risk Assessment and determination of the safety profile of a product 
•    Analysis of unlisted (unlabeled) serious and non-serious reactions 
•    Responsibility for input into the safety management of assigned products, which includes signal detection, benefit risk analysis, analysis of individual cases, preparation of aggregate reports, responding to requests from health authorities, and the risk management 
•    Taking part in the review of /inputting to investigator brochure content, expert reports, and pooled study data 
•    Providing Patient Safety input into the setting up and updating of safety data exchange agreements
•    Supervising vendors/contractors providing safety services for their compounds 
•    Participate in the medical/scientific review of products subject to licensing-in agreements 
•    Provide input to high level training initiatives within functional areas and project teams 
•    Responsibility with the SL for the combined (clinical study and post marketing sources) Safety Signal Detection process.

 

About You
You should have/be:
•    At least 7 years of relevant experience with at least 3 years within Patient Safet
•    In-depth knowledge and understanding of applicable regulations, quality principles, relevant business processes and techniques
•    Good background knowledge of the (bio)pharma industry and applicable technical aspects of the business
•    Understands practical applications of drug safety related and/or GxP, compliance principles and theories incl. risk management
•    Thorough understanding of business and cultural drivers. Skilled and experienced at operating in a cross-cultural team environment
•    Understands principles of cost-and time-efficiency 
•    Effectively deals with conflicts
•    Ability to distil complex principals into clear, easily understood concepts
•    Fluent command of the English language (written and spoken) 
•    Effective listening skills
•    Able to deliver presentations or reports to senior management or industry audiences with a relaxed and proficient presentation style
•    Capable of leading and motivating interdepartmental teams

 

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 7500 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.


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