PV Quality Management Senior Manager (m/f/x)

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 Euoprean headquarters in Munich we are looking for a

PV Quality Management Senior Manager (m/f/x)

The position:

This position will support the DSE Pharmacovigilance (PV) Quality Management Lead in all aspects of its activities to ensure PV operational standards are being achieved with excellence. Activities include but are not limited to, 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) with the focus specifically on the QMS areas of procedural documents and training.
This position will also act as Deputy to the PV Quality Management Lead during periods of absence.  

Roles & responsibilities:

• Ensure relevant operational standards are well-maintained and continuously improved                                   

  • Collaborate on content creation with subject matter experts based on own substantial understanding of pharmacovigilance processes and system

  • Create, review and disseminate procedural documents

  • Define and manage internal training compliance

  • Identify process improvements and harmonizations leading to enhancement and implementation of appropriate processes

  • Contribute to planning, steering and coordination of projects together with the PV Quality Management Lead and other team members as part of global worstreams                                    

• Organize and coordinate training-related activities and projects

  • Define, monitor and manage internal training compliance

  • Project manage with subject matter experts on training content creation 

  • Lead/organise appropriate onboarding and continuous trainings at regional and global level according to industry standards

  • Identify and implement strategy for process improvements                                    

• Involvement and contribution to global/local discussion/project for continuous Quality Management System enhancement

  • Support to define, manage, maintain and coordinate procedures continuously improving quality in collaboration with the CSPV group

  • Proactively monitor quality of pharmacovigilance tasks and related processes and faciliatate appropriate actions with subject matter experts

  • Bring ideas for potential process improvement/global harmonisation based on industry standards and bench-marking

  • Support implementation of systems/tools for process improvement/enhancement              

Professional experience & eduction:

• University degree

• 5 to 8 years experience

• Broad PV knowledge and experience of procedural systems as part of the quality management system

• Experience with training activities in the GxP environment

• Project steering abilities

• 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?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

For more information: www.daiichi-sankyo.eu