PV Quality Management Senior Manager

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 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.

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