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?
To strengthen our global Patient Safety and Medical Management (PSMM) group we are looking for a talented individual that resides and operates in Europe to fill the position of EEA Qualified Person for Pharmacovigilance (EEA QPPV). This role will also take a global perspective in their contribution to the wider Patient Safety department. This role reports into the Head of Patient Safety and Medical Management (PSMM) and as such is a member of the PSMM Leadership Team
As the EEA QPPV you will hold an executive position with the objective of fulfilling the legal requirements of the EEA QPPV as defined by prevailing European legislation and also ensure that UCB operates in accordance with Pharmacovigilance EEA regulatory standards and that compliance risks are identified and mitigated.
You will work in environment that is defined by Legal Framework/Authority
- The EEA QPPV is responsible for the establishment, maintenance, compliance and continuous improvement of UCB’s pharmacovigilance system in accordance with the legal framework for pharmacovigilance of medicinal products for human use in the EU given by the Regulation (EU) No 1235/2010 amending Regulation (EC) No 726/2004, by the Directive 2001/83, as amended in 2010 by Directive 2010/84/EU, as well as by the Commission Implementing Regulation (EU) N° 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities and in the associated guidelines of good pharmacovigilance practices (GVP)
- At UCB, The EEA QPPV has oversight and exercises authority over the functioning of the Pharmacovigilance system in all relevant aspects, including its quality system, the EEA QPPV is a member of the following UCB Governance Bodies:
- Pharmacovigilance Quality Council (PVQC)
- Global Labeling Committee (GLC)
- Benefit-Risk Board (BRB)
- Individual Case Safety Report (ICSR) Quality Forum (IQF)
- Recall Committee
- Patient Safety (PS) Portfolio Governance Committee
- Shall act as the single PV contact point for the national competent authorities and the Agency on a 24-hour basis and as a contact point for PV inspections
- Shall be accessible continuously and when unavailable will nominate a back-up
- Shall lead the network of other local QPPVs to ensure sharing of information and expertise
- In relation to the PV system, is responsible for the establishment and maintenance of the UCB PV system in accordance with the legal framework for PV of medicinal products for human use in the EEA – supported by the PV Excellence team
- In the EEA, this implies that the EEA QPPV shall:
- have the authority to influence the performance of the company PV system and its related quality system in order to promote, maintain and improve compliance with the legal requirements
- have oversight over the functioning of the PV system in all relevant aspects including the PSMF and the PV quality system
- have an additional dotted line reporting to the Global Head of Internal Audit. With this connectivity a Pharmacovigilance Auditing Committee occurs to provide top-line visibility of the PVQA risk assessments, audit plans, audit execution and CAPAs
- In relation to the products for which UCB holds a marketing authorization in the EEA, specific responsibilities of the EEA QPPV include those described in GVP Module I and the maintenance of the overview on the specific tasks that are delegated
- Understand the direction of travel of EU Authorities and enable UCB to proactively align with regulatory expectations
- Support ongoing evolution of the PV system to prepare for the future by ensuring appropriate prioritisation of activities by a pragmatic approach balancing acceptable risk taking and effective targeting of available resources
- Influences external environment and develops a strong within industry and regulators acts proactively as a UCB representative within external organizations (e.g. patient interest groups, industry trade associations, congress etc.)
- Demonstrates integrity in decision making and builds trust inside and outside UCB
- Shall ensure that the deputy QPPV has all necessary information to fulfill the role, and that the 24 hour contact details of the EEA QPPV and deputy QPPV have been notified to all regulatory authorities in which marketing authorizations are held within their respective territories and to the Agency.
- A Medical Degree
- At least 15 years’ experience within the Pharma Industry (medical or clinical development) with at least 8 years of experience in pharmacovigilance
- A strong focus on the patient in all decision making
- Technical knowledge of EEA PV requirements and their implementation vs international requirements and in-depth knowledge of European regulations
- Solid scientific/medical: Shall be highly qualified profile in PV and related matters such as medicine, pharmaceutical sciences as well as epidemiology, biostatistics, data integrity etc.
- Pragmatic and Prioritization mindset to effectively balance risks in context of reality
- Leadership skills
- Leadership and decisiveness- ability to delegate, to choose the tasks and the levels of supervision that can be delegated,
- Should be a central agent who assumes a lead role in PV and share experience and challenges with UCB local QPPVs (maybe a dotted line?)
- Resilience and Patience
- Excellent communication skills. strong communication skills & negotiating skills
- Demonstrates integrity and inspires trust (internally and externally)
- Has a long term vision for PV (for products authorized in the EEA) in the globalisation environment
At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.
In PSMM we have an experienced and committed leadership team who focus on the people in the team as well as the delivery of the strategic objectives. This means we have a very strong team who are supportive and collaborative who enjoy working together.
If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.
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 .
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer.