European Qualified Person for Pharmacovigilance (EU QPPV) - Mechelen, BE - Leiden, NL
Pleased to meet you, we are Galapagos, a dynamic fast growing biotech company with offices in Europe, in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Switzerland (Basel) and in the US (Boston).
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists, we need the best-in-class. In other words, we need you: The ‘make-it-happeners’.
Scope of work
The EU-QPPV is the accountable person for the pharmacovigilance activities of Galapagos. The EU-QPPV has the authority over the pharmacovigilance system (PV system) within GLPG which allows the QPPV to implement changes to the system and to provide input into risk management plans as well as into the preparation of regulatory action in response to emerging safety concerns. He/she serves as a member of the GLPG global matrix organization interacting with key stakeholders both internally and externally. He/she has interfaces across all levels and functional areas and needs to partner closely with the clinical development and commercial teams.
- Oversight of the GLPG PV System
- To ensure that a compliant PV system is set up and maintained in collaboration with other internal interfaces. This includes its quality system (e.g. standard operating procedures, key performance indicators, the pharmacovigilance system master file (PSMF), contractual arrangements, signal management compliance data regarding quality, audit reports and training of personnel in relation to pharmacovigilance)
- To ensure the timely submission of pharmacovigilance-related documents in accordance with the statutory requirements. To ensure the required quality, including the accuracy and completeness, of the PV data submitted to the competent authorities in the EU Member States and to the European Medicines Agency (EMA).
- To act as the primary contact for pharmacovigilance inspections.
- To review the schedule for pharmacovigilance audits and to trigger an audit where considered appropriate.
- To review the corrective and preventive action plan following each audit relevant to the GLPG PV system in order to assure that appropriate corrective actions are implemented.
- To maintain awareness of the sections of any contractual arrangements with third parties that relate to responsibilities for pharmacovigilance activities and safety data exchange in order to ensure that all necessary provisions relevant to the pharmacovigilance system are included and to request amendments where appropriate.
- To manage the Good Pharmacovigilance Practice (GVP) Council.
- To participate as a member in other compliance-relevant internal decision-making bodies.
- Oversight of the benefit/risk profile of approved GLPG medicinal products
- Oversight of the benefit/risk profile of GLPG medicinal products, including the benefit/risk management activities and emerging safety concerns.
- To participate in the Safety Board Meetings.
- To maintain an awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products.
- To possess knowledge of regulatory requirements relating to the safety or safe use of approved products.
- To approve risk management plans, post-authorisation safety studies and Periodic Safety Update Reports (PSUR).
- To ensure a complete and timely response to requests from the competent authorities in EU Member States and the EMA to supply additional information needed for the benefit/risk assessment of medicinal products.
- To provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals)
- To lead crisis management in response to emerging safety concerns.
- Collaboration with internal interfaces
- The EU QPPV ensures that all relevant internal interfaces are informed of all current safety issues and contributions to the PV system.
- Promotes, maintains and improves compliance with the PV legal requirements within the EU
- Manages and develops PV staff in EU and collaborates with the cross functional teams
- Collaboration with external interfaces
- The EU QPPV acts as the contact person for the responsible authorities on a 24/7 basis.
- Responsible for obtaining relevant regulatory intelligence information to assist GLPG in assessing the impact of changes to regulations and related directives on the pharmacovigilance system.
- Represents GLPG in interactions with EU authorities and industrial associations in PV-related matters.
- Informs relevant competent authorities in Member States immediately of any important safety concern identified in the course of a study.
- Retains an establishment within the EU/EEA for the duration of the contract
Who are you?
- Qualified Healthcare Professional with 5-10 years of experience in relevant fields; MD preferred.
- Adequate theoretical and practical knowledge for the performance of pharmacovigilance activities [IR (EU) 520/2012, Art 10 (1)]. Skills for the management of pharmacovigilance systems as well as expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences as well as epidemiology and biostatistics.
- The QPPV shall reside and operate in the EU [DIR 2001/83/EC, Art 104 (3)]. Following European Economic Area (EEA) agreements, the QPPV may also reside and operate in Norway, Iceland or Liechtenstein.
- Entrepreneurial, hands-on, with perseverance and problem-solving skills.
- Able to work independently and effectively in complex, rapidly changing environments.
- Sense of urgency.
- Flexibility, diplomacy, and the ability to manage expectations.
- Strong presentation/interaction and time management skills.
- Proven ability to establish strong partnerships with key internal and external stakeholders.
- Thorough understanding of local compliance, as well as a sound ethical approach to business.
- A genuine passion for science and in making a difference in patient's lives.
What’s in it for you?
You will be part of a fast growing and amazing company. You will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos: together we can make it happen…!