Manager, Clinical Safety Scientist (m/f/x)

Daiichi Sankyo; München; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Manager, Clinical Safety Scientist to enhance patient safety through proactive risk management and safety surveillance. This role involves collaborating with cross-functional teams to evaluate safety data, develop materials for regulatory submissions, and contribute to safety action plans. If you have a passion for innovation and a commitment to improving patient outcomes, this position offers a unique opportunity to make a meaningful impact in the field of oncology and drug development. Join a culture that values respect, continuous learning, and diversity, and be part of a team dedicated to making a difference in patients' lives.

Qualifikationen

• Bachelor’s degree required; PharmD or PhD preferred.
• At least 2 years of experience with an advanced degree or 4 years with a bachelor’s degree.

Aufgaben

• Support safety surveillance and risk management for clinical studies.
• Evaluate safety data to identify potential signals and perform safety analyses.
• Develop safety-related materials for regulatory submissions.

Kenntnisse

Safety Data Summarization

Project Management

Analytical Skills

Cultural Sensitivity

Knowledge in Oncology

Ausbildung

Bachelor's Degree

PharmD

PhD

Jobbeschreibung

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Manager, Clinical Safety Scientist (m/f/x)

Date: 6 May 2025

Passion for Innovation. Compassion for Patients.

Daiichi Sankyo, with over 120 years of experience and approximately 19,000 employees across more than 30 countries, is dedicated to discovering, developing, and delivering new standards of care that improve quality of life worldwide.

In Europe, our focus areas include: protecting people from cardiovascular disease, the leading cause of death in Europe, and supporting patients suffering from it; and driving innovation in oncology, particularly in solid tumors and blood cancers, based on breakthrough science from our labs in Japan.

Our European headquarters are located in Munich, Germany, with affiliates in 15 European countries and Canada.

We are seeking a highly qualified candidate for the position of:

Manager, Clinical Safety Scientist (m/f/x)

The Position:

The successful candidate will support proactive safety surveillance and risk management for assigned products, collaborating with Clinical Safety Scientist Product Lead, Product Safety Lead, Clinical Safety Physicians, and cross-functional teams to manage the benefit-risk profile throughout the product lifecycle. The role includes acting as the Clinical Safety Scientist lead in post-marketing activities and for specific clinical studies and safety analyses as needed.

Roles and Responsibilities:

• Support safety surveillance and risk management for clinical studies, working with cross-functional teams to oversee the product’s benefit-risk profile.
• Evaluate safety data from various sources to identify potential signals, track these signals, and perform safety analyses. Contribute to safety action plans and communicate findings to relevant teams.
• Develop safety-related materials for safety meetings and regulatory submissions, including safety sections of study documents, reports, and product information.
• Coordinate safety meetings, maintain documentation, and may serve as project manager for assigned activities.

Personal Skills and Professional Experience:

• Bachelor’s degree required; PharmD or PhD preferred.
• At least 2 years of experience with an advanced degree or 4 years with a bachelor’s degree.
• Experience in safety data summarization, project management, and working in a matrix environment.
• Knowledge in oncology and drug development, and familiarity with international and European PV laws.
• Fluent in business English, with high reliability, accuracy, analytical skills, and cultural sensitivity.

Why work with us?

Joining Daiichi Sankyo means making a difference in patients’ lives. We promote a culture of mutual respect, continuous learning, inclusion, and diversity. We offer opportunities for growth, innovation, and meaningful contribution. If you are proactive and passionate about patient needs, we look forward to your application.