Head of Safety Risk Management Excellence
il y a 3 jours
**Make your mark for patients.**
We’re here because we want to build the future and transform patients’ lives for the better.
At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.
An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?
To strengthen our **Patient Safety & Medical Management function**, based in our either of our **Brussels (Belgium, Monheim (Germany), Slough (UK) or Raleigh (US) offices** we are looking for a talented individual to fill the position of **Head of Safety Risk Management Excellence & Innovation**.
As the **Head of Safety Risk Management Excellence & Innovation** you will have the following responsibilities:
- Preparedness for acquisition and development of novel therapy assets
- Coaching / mentoring SRM team members as needed to ensure high quality contributions to relevant SRM deliverables
- Evaluate and create tools to build and develop relevant competencies for new trends within industry in relation to pharmacovigilance and emerging therapeutic modalities within the SRM team
- Develop/maintain processes, tools, and standards which foster quality, innovation and efficiency to ensure that all safety management projects are managed and executed
- Provide technical review of safety documents such as SSAR/SER/RMP within SRM to improve technical expertise in SRM and hence quality of outputs
- Participate in governance/review meetings when appropriate (GLC, BRB, SCRC etc.).
- Ensure adherence and compliance with current world-wide PV regulations, SOPs, GVP and quality standards applicable to UCB.
- Develop skill set of assigned personnel which emphasizes team work, collaboration, innovation, decision making and to ensure industry leadership in safety risk management
- Participate and advise on licensing, partnering, and acquisition opportunities.
- Other responsibilities, delegation of governance meetings and projects that may be assigned.
- In collaboration with other SRM LT members, identify areas of strength and opportunity amongst SRM team members. Conduct needs assessment, identify gaps in skill and provide appropriate training/guidance through mentorship and/or identifying other developmental opportunities
- Future proofing and change management as we identify and build new competencies and move into new areas
- eg automation/gene therapy/devices
- Ensuring SRM leadership in benefit risk assessment and signal detection for current and upcoming trends in drug development
- Preparedness and participation in PV inspections and audits as required
- Support SRM team on development of CAPA plans
You will **contribute** by:
- PhD, PharmD, MD preferred
- Proven and successful track record in biopharmaceutical clinical development and at least one of the following areas: risk management, pharmacoepidemiology or pharmacovigilance.
- Broad knowledge of global PV regulations
- Experience in business diligence activities
- Knowledgeable of relevant concepts in health care, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance, drug development and statistics
- Proven leadership skills that provides guidance in the successful medical, scientific and project management of safety activities. Substantial personal experience with GVP.
- Substantial personal experience of presenting to and interacting with regulatory agencies essential to ensure adequate coaching of function members
- Experience working with gene therapy, biologics, small molecules and additional work with devices would be advantageous
- Drug development experience spanning the full drug development lifecycle.
Interested? For this position you’ll need the following **education**, **experience** and **skills**:
**Why you should apply**
At UCB, we welcome passionate individuals who thrive on change and are ready make their mark for patients. Working for us, you will discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact while putting continuous efforts into cultivating a workplace culture where everyone feels included, respected and has equitable opportunities. Through meaningful recognition and a motivating atmosphere, we aim to provide an optimal experience by caring about and valuing our employees - just as we do for the patients we serve.
**About us.**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.
At UCB, everything we do start with a simple question: “How will this create value
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