Deputy EU QPPV in Deutschland bei BeiGene
Deputy EU QPPV in Deutschland bei BeiGene
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Deputy EU QPPV together with the EU QPPV is responsible for maintaining, overseeing and promoting BeiGene’s pharmacovigilance system and overseeing the benefit-risk profile of BeiGene’s medicinal products authorized in the European Union (EU). During the absence of the QPPV, the Deputy assumes the responsibilities as BeiGene’s EU QPPV according to EU Directive 2001/83/EC Art. 103 and GVP Module I. The Deputy EU QPPV is responsible for organizing the QPPV Council, an exchange forum of all QPPVs and Local Safety Representatives globally working for BeiGene. To maintain and improve BeiGene’s PV system, the Deputy QPPV will work closely with other teams within GPS, as well as other departments and external partners. As a member of the QPPV Office, the Deputy EU QPPV will represent the QPPV Office in GPS-internal or cross-functional projects and working groups and support PV audits and inspections.
Reports To: EU QPPV
Education Required:
- Medical, pharmacy or life sciences degree (or equivalent; Master, PhD or MD)
- Minimum of 6 years’ experience within Patient Safety
- Expert knowledge of Good Pharmacovigilance Practices (GVP)
- Minimum of 2 years’ experience as EU QPPV or Deputy EU QPPV or in a role directly supporting the EU QPPV (e.g., in the QPPV Office)
- Fluent in written and spoken English, second European language an advantage)
Essential Functions of the job:
- Supports the EU Qualified Person responsible for PV (EU QPPV) in the establishment and maintenance of BeiGene’s pharmacovigilance system, influencing the performance of the quality system and the pharmacovigilance activities and promoting, maintaining, and improving compliance with the EU legal requirements
- Ensures and verifies that the information contained in the PSMF is an accurate and up-to-date reflection of the pharmacovigilance system by reviewing and approving the PSMF
- During the absence of the EU Qualified Person responsible for PV (EU QPPV), the Deputy EU QPPV assumes the responsibilities according to EU Directive 2001/83/EC Art. 103 and GVP Module I, including the responsibilities mentioned above and, in relation to the medicinal products covered by the pharmacovigilance system, i.e. the medicinal products authorized in at least one member state in the EU:
- Has an overview of the product safety profiles and any emerging safety concerns
- Has awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products
- Has awareness of risk minimization measures
- Is aware of and has sufficient authority over the content of risk management plans
- Is involved in the review and sign-off of protocols of post-authorization safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU
- Has awareness of post-authorization safety studies requested by a competent authority including the results of such studies
- Ensures conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP
- Ensures the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in EU Members States and the EMA
- Ensures a full and prompt response to any request from the competent authorities in EU Members States and from the EMA for the provision of additional information necessary for the benefit risk evaluation of a medicinal product
- Provides any other information relevant to the benefit-risk evaluation to the competent authorities in the EU Members States and the EMA
- Provides 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)
- Acting as a single pharmacovigilance contact point for the competent authorities in the EU Member States and the EMA on a 24-hour basis and also as a contact point for pharmacovigilance inspections
- Oversees the functioning of the PV system in all relevant aspects, including its quality system (e.g. standard operating procedures, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in r