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

TN Spain

All

Presencial

EUR 30.000 - 50.000

Jornada completa

Hace 26 días

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Descripción de la vacante

An established industry player is seeking a passionate PV Quality Management Senior Manager to enhance patient safety standards through effective pharmacovigilance practices. This role offers the opportunity to lead quality management initiatives, collaborate with experts, and implement process improvements that directly impact patient care. You will be part of a dynamic team dedicated to innovation and excellence in the pharmaceutical field. If you thrive in a collaborative environment and are eager to make a difference, this position is perfect for you.

Formación

  • 5 to 8 years of experience in pharmacovigilance and quality management.
  • Strong project management and communication skills required.

Responsabilidades

  • Ensure operational standards in pharmacovigilance are met and improved.
  • Collaborate on procedural document creation and training compliance.

Conocimientos

Pharmacovigilance knowledge
Project management
Analytical skills
Communication skills
Problem-solving skills
Training compliance management
Process improvement

Educación

University degree

Herramientas

Quality Management System (QMS)
GxP training tools

Descripción del empleo

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

Location: All, Spain

Job Category:

Other

EU work permit required:

Yes

Job Views:

2

Posted:

25.04.2025

Expiry Date:

09.06.2025

Job Description:

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 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 a 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.

  1. Ensure relevant operational standards are well-maintained and continuously improved.
  2. Collaborate on content creation with subject matter experts based on own substantial understanding of pharmacovigilance processes and systems.
  3. Create, review, and disseminate procedural documents.
  4. Define and manage internal training compliance.
  5. Identify process improvements and harmonizations leading to enhancement and implementation of appropriate processes.
  6. Contribute to planning, steering, and coordination of projects together with the PV Quality Management Lead and other team members as part of global workstreams.
  7. Organize and coordinate training-related activities and projects.
  8. Define, monitor, and manage internal training compliance.
  9. Project manage with subject matter experts on training content creation.
  10. Lead/organize appropriate onboarding and continuous training at regional and global level according to industry standards.
  11. Identify and implement strategy for process improvements.
  12. Involvement and contribution to global/local discussion/project for continuous Quality Management System enhancement.
  13. Support to define, manage, maintain, and coordinate procedures continuously improving quality in collaboration with the CSPV group.
  14. Proactively monitor quality of pharmacovigilance tasks and related processes and facilitate appropriate actions with subject matter experts.
  15. Bring ideas for potential process improvement/global harmonization based on industry standards and benchmarking.
  16. Support implementation of systems/tools for process improvement/enhancement.

Professional experience & education:

University degree

  1. 5 to 8 years experience
  2. Broad PV knowledge and experience of procedural systems as part of the quality management system
  3. Experience with training activities in the GxP environment
  4. Project steering abilities
  5. Good or excellent computer and presentation skills
  6. Good or excellent written and verbal communication skills in English
  7. Highly reliable with accurate operating principles
  8. Analytic and systematic approach with good problem-solving skills
  9. Ability to understand complex matters with a continuous focus on improvement
  10. Substantial communication skills, in particular also on intercultural level with respect and appreciation of cultural diversity
  11. Proactive, autonomous and reliable working style paired with the ability to work in international matrix teams
  12. 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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