Manager, PV QA Europe (m/f/x)

Daiichi Sankyo; Paris; Sur place; EUR 60 000 - 95 000; Plein temps

Résumé du poste

An established industry player is looking for a Manager in Pharmacovigilance Quality Assurance to lead quality initiatives across Europe. This role involves collaborating with various teams to ensure compliance with regulatory standards and promoting a culture of quality and excellence. The ideal candidate will have extensive experience in Quality Assurance within the pharmaceutical sector, particularly in Pharmacovigilance. You will be instrumental in driving continuous improvement and supporting strategic projects that enhance patient safety and regulatory compliance. Join a passionate team dedicated to innovation and patient care, and make a significant impact in the field of healthcare.

Qualifications

• 5+ years in pharmaceutical or biotech Quality Assurance.
• Experience in Pharmacovigilance QA and Clinical Safety.

Responsabilités

• Support implementation of Quality Assurance strategy within CSPV.
• Provide QA guidance and support to projects and initiatives.
• Collaborate with cross-functional teams to address compliance concerns.

Connaissances

Pharmacovigilance QA

Quality Assurance

Risk Assessment

Regulatory Compliance

Interpersonal Skills

Formation

Bachelor’s degree in scientific or life sciences

Master’s or other advanced degree

Trained PV QA Auditor certification

Description du poste

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Manager, PV QA Europe (m/f/x)

Date: 7 May 2025

Location: All Europe, Europe, UB8 1DH

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 a 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.

We are seeking a highly qualified candidate to fill the position:

Manager, Pharmacovigilance Quality Assurance (PVQA), Europe (m/f/x)

The Position:

The position will collaborate to support the implementation of the Quality Assurance strategy within the Clinical Safety and Pharmacovigilance (CSPV) function in Europe. Responsibilities include providing proactive QA guidance and support to projects and initiatives, consulting with management, ensuring communication with EU QPPV and other colleagues in CSPV, offering advice on issue investigation and solution implementation. The role collaborates with the Global Audits and Compliance group, Development and Medical Affairs QA, Quality Management Systems QA, and GMP QA as needed. Additionally, the role involves supporting quality risk management activities, facilitating knowledge management, participating in inspections and audits, and collaborating with cross-functional teams to address safety and compliance concerns. This role is dedicated to activities in Europe but may support global activities as necessary.

The individual is expected to support proactive and strategic collaboration with CSPV, providing operational QA guidance and support with regulatory document execution/review, and advising on adherence to procedural documents and training programs. Continuous improvement of quality and compliance, interpretation of regulations and company standards, creation and review of relevant procedural documents, and cooperation with Daiichi Sankyo's Global Quality Assurance Organization are also part of the role. Lastly, the individual is responsible for advocating Daiichi Sankyo's Quality policy and culture.

Support planning and implementing the Quality Assurance strategy within CSPV, aligned with business strategy and objectives, through effective communication and collaboration with the EU QPPV and CSPV colleagues, fostering a cohesive approach to quality management and ensuring regulatory compliance.

Provide proactive QA guidance and support to CSPV projects and initiatives, ensuring compliance oversight, closely aligned with the Regional Head of PV QA.

Interact with other areas such as Legal, Regulatory Affairs, Development and Medical Affairs QA, GMP QA, and Quality Management Systems as required.

Offer consultation, advice, and support in investigating and resolving complex issues (e.g., Quality Deviations, Quality Events), overseeing corrective and preventive actions, including Root Cause Analysis (RCA), and monitoring progress for timely closure.

Collaborate with the Global Audits and Compliance group to support audit programs (e.g., affiliates, vendors), and oversee the monitoring of findings and CAPAs.

Support risk management activities related to product safety, including trend analysis of KPIs from a PV QA perspective, offering recommendations for improvement.

Support QA leadership in working groups and meetings related to strategic alliances with partners.

Coordinate CSPV teams in preparing for regulatory inspections and audits, actively managing these processes.

Facilitate knowledge sharing initiatives, best practices, lessons learned, and process improvements to enhance CSPV operations.

Collaborate with cross-functional teams locally and globally to address safety and compliance concerns.

Proactively act as the QA point person for CSPV matters, providing operational leadership and guidance to ensure compliance with regulatory standards and robust quality systems.

Support the review and execution of key CSPV regulatory documents, such as Health Authority Commitments, Pharmacovigilance Agreements, Safety Data Exchange Agreements, and the Pharmacovigilance System Master File, managing escalations and CAPAs to address risks or issues.

Advise CSPV teams on procedural adherence and training, fostering staff competence and compliance.

Drive continuous improvement initiatives, collaborating with stakeholders to enhance quality and compliance practices.

Review, develop, and harmonize procedural documents, addressing gaps or inconsistencies.

Develop, deliver, and monitor training programs for stakeholders to ensure understanding of quality and compliance requirements.

Collaborate with Daiichi Sankyo’s Global Quality Organization to develop and maintain the global and local quality management systems.

Champion Daiichi Sankyo’s Quality policy and culture, promoting a commitment to excellence and continuous improvement across CSPV functions.

Travel globally as needed.

Qualifications:

Education

Bachelor’s degree in scientific or life sciences, such as Pharmacy, or related discipline.

Master’s or other advanced degree preferred.

Trained PV QA Auditor certification.

Knowledge of PV regulations and guidelines (FDA, EMA, ICH).

Fluent English skills.

Experience

• At least 5 years in pharmaceutical or biotech Quality Assurance.
• Experience in Pharmacovigilance QA.
• Experience in Clinical Safety and Pharmacovigilance.

Analytical, systematic, and well-versed in risk assessment.

Reliable, accurate, with strong interpersonal, negotiation, and problem-solving skills, and cultural sensitivity.