Pv Quality Management Specialist

vor 2 Wochen

Munich, Deutschland Daiichi Sankyo Europe Vollzeit

**Passion for Innovation. Compassion for Patients.**:
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

For our European headquarters in Munich we are looking for a

**PV Quality Management Specialist (M/F/x)**:
**The position**:
The PV Quality Management Specialist will work with and support the PV Quality Management team to maintain and enhance the Daiichi Sankyo PV Quality Management System.This position is responsible for the quality control of PV tasks fulfilled by DSE (EU headquarter office), EU affiliates, CROs and license partners and proactively monitors quality of all PV tasks (including compliance monitoring) and ensures operational standards are well-maintained.
This position will also support other activities in the PV quality management area as needed for the overall optimal function of the team and is expected to contribute to the global projects together with the PV Quality Management Lead and other team members as part of the global Quality, Compliance and PSMF team to enhance the Daiichi Sankyo Global PV Quality Management System.

**Roles & responsibilities**:

- Global maintenance of PSMF and related documents as well as global coordination of all PSMF related activities with relevant stakeholders (cross-regional and cross-functional)
- Manage and maintain the global Phamarcaovigilance System Master File
- Organize compilation activties including vendor coordination
- Identify process improvements and harmonizations
- Systematical deviation Management, CAPA plan development and tracking of CAPA status for deviations of any source
- Coordination of planned CAPA activities with relevant CAPA stakeholders
- Collection of implemented items
- Review/QC evidence ensure consistency with the CAPA plan
- Coordination and handling of escalated quality events in collaboration with QA functions in the trackwise system
- Act as system expert for RxLogics in the context of compliance/KPI outputs
- Plan, coordinate and process compliance as well as KPI report
- Provide appropriate data visualization
- Analyse and identify concerns and key messages from the data
- Continuously identify and propose process enhancement of the system

**Professional experience & education**:

- Bachelor degree in a scientific and/or quality related area, Master preferred
- 2-5 years in PV Quality related tasks
- Experience in the field of safety data processing or CAPA management
- Experience with PSMF related work and knowledge of respective regulations
- Good or excellent computer and presentation skills
- Good or Excellent written and verbal communication skills in English
- Highly reliable with accurate operating principles
- Analytic and systematic approach with good problem solving skills
- Ability to understand complex matters with a continuous focus on improvement
- Substantial communication skills, in particular also on intercultural level with respect and appreciation of cultural diversity
- Proactive, autonomous and reliable working style paired with the ability to work in international matrix teams
- Flexible and adaptable

**Why work with us?**:

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