Principal Investigator Leipzig Vollzeit Velocity Clinical Research, Inc. Doctoral Student (Ph.D.) in Digital Health (m/f/d) Potsdam Vollzeit Hasso-Plattner-Institut Clinical Trial Administrator (m/f/d) - Germering, Germany Germering Vollzeit Optimapharm d.o.o.
Gestalte deine Karriere als Patient Safety Europe Lead bei BeiGene in Deutschland
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BeiGene
Deutschland
Stellenausschreibung
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 Patient Safety Europe Lead together with the Local Safety Representatives (LSRs) in each European country ensures that all local pharmacovigilance (PV) activities are performed as required by European and local legislation, as well as BeiGene’s process documents. LSRs are provided by GPS, other BeiGene departments, service providers or partner companies, and the PV activities in all countries are supported by GPS-contracted service providers. Therefore, the Patient Safety Europe Lead is an important interface to and supporter of not only the LSRs, but also other stakeholders. In addition, the Patient Safety Europe Lead works closely with the GPS International Office to support, maintain and improve the international PV operations, as well as the QPPV Office and GPS Quality Management Operations to provide an overview of the European PV system status and compliance, and to support PV audits and PV inspections.
Essential Functions of the job:
- Oversee and enable local PV activities performed by European LSRs and service providers
- Set up and manage a Patient Safety Europe Working Group with European LSRs, QPPV Office and other stakeholders to oversee, support and improve European PV operations
- Support and work with the GPS International Office and Safety Operations, to support, maintain and improve local PV operations on a global level
- Member of the GPS International Operations Committee
- Interact with and support Vendor Oversight of service providers providing LSRs and local PV operations
- Interact with and support PV Alliance activities with commercial partners providing LSRs and local PV operations
- Oversee, support and report on PV compliance to QPPV Office and GPS Quality Management Operations to ensure to PV inspection readiness
- Support and participate in PV audits and PV inspections
- On- and off-boarding of European LSRs or their deputies
- Ensure relevant information for local PV oversight is available to the European LSRs
- Support assessment of PV-relevant legislative changes on the European level or in a European country
- PV activities forecast for Europe and budget planning and control together with QPPV Office, GPS International Office and GPS Vendor Oversight
- Support GPS or interdepartmental projects with relevance to local PV activities
- Represent BeiGene in the European PV community as European PV operations expert (conferences, working groups, industry associations)
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 leading a team responsible for local or regional pharmacovigilance operations in Europe or a major European country or as National PV Contact Person (per GVP)
- Fluent in written and spoken English, second European language an advantage)
Supervisory Responsibilities:
Oversight of European LSR performance and local PV compliance:
- Direct reporting line for LSRs provided through GPS or GPS-contracted service providers
- Indirect reporting line for LSRs provided through other BeiGene departments or commercial partner companies
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent
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