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

Daiichi Sankyo; Uxbridge; On-site; GBP 50,000 - 70,000; Full time

Job summary

Daiichi Sankyo seeks a Manager for Pharmacovigilance Quality Assurance in Europe. This role focuses on implementing QA strategies, overseeing investigations, and ensuring compliance with regulatory standards in a dynamic pharmaceutical environment. Ideal candidates will possess a relevant degree and significant experience in quality assurance, contributing to the company's commitment to patient safety.

Qualifications

• At least 5 years in pharmaceutical or biotech Quality Assurance.
• Experience in Pharmacovigilance QA and Clinical Safety.
• Knowledge of PV regulations (FDA, EMA, ICH).

Responsibilities

• Support implementation of QA strategy within the CSPV function.
• Oversee issue investigations and collaborate on audits.
• Support risk management and ensure compliance with regulatory standards.

Skills

Analytical approach

Problem-solving

Communication

Interpersonal skills

Teamwork

Cultural sensitivity

Education

Bachelor’s degree in Pharmacy, Life Sciences, or related field

Master’s or higher degree preferred

Trained PV QA Auditor

Job description

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

Location: All Europe, Europe, UB8 1DH

Passion for Innovation. Compassion for Patients.

Daiichi Sankyo, with over 120 years of experience and more than 17,000 employees across 20+ countries, is dedicated to discovering, developing, and delivering new standards of care to improve lives worldwide.

In Europe, we focus on cardiovascular disease and oncology, aiming to protect and treat patients effectively. Our European headquarters are in Munich, Germany, with affiliates in 13 European countries and Canada.

We seek a qualified candidate for the role of:

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

The Position:

This role involves supporting the implementation of the PV QA strategy within the CSPV function in Europe, providing QA guidance, consulting with management, ensuring communication with EU QPPV, and supporting audits, inspections, and cross-functional collaboration. The role may also support global activities as needed.

The individual will support proactive QA guidance, oversee issue investigations, collaborate on audits, support risk management, and contribute to continuous improvement initiatives. The role requires close interaction with various departments, supporting regulatory inspections, facilitating knowledge sharing, and ensuring compliance with regulatory standards.

Responsibilities include supporting QA strategies, providing operational guidance, overseeing investigations and CAPAs, supporting risk management, preparing for inspections, fostering knowledge sharing, and collaborating globally to address safety and compliance concerns. The role also involves developing and reviewing procedural documents, delivering training, and promoting Daiichi Sankyo’s Quality culture.

Qualifications:

Education:

• Bachelor’s degree in Pharmacy, Life Sciences, or related field
• Master’s or higher degree preferred
• Trained PV QA Auditor
• Knowledge of PV regulations (FDA, EMA, ICH)

Experience:

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

Skills include analytical approach, risk understanding, reliability, interpersonal skills, problem-solving, cultural sensitivity, teamwork, and communication.