(Senior) Director Safety Physician - ADC (m/f/x)

TN Germany; München; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

An established industry player seeks a passionate and experienced (Senior) Director Safety Physician to lead global safety strategy for oncology products. This pivotal role focuses on risk management and safety monitoring, ensuring compliance with regulations while collaborating with key stakeholders. Join a dynamic team dedicated to improving patient lives through innovative therapies. If you are proactive and committed to patient safety, this is the opportunity for you to make a significant impact in a supportive and inclusive environment.

Qualifikationen

• Minimum 5 years of experience in pharmacovigilance or related fields.
• Strong knowledge of international legislation on pharmacovigilance.

Aufgaben

• Responsible for global safety strategy and risk management for oncology products.
• Collaborate with internal and external stakeholders on safety monitoring.

Kenntnisse

Pharmacovigilance

Risk Management

Analytical Skills

Communication Skills

Interpersonal Skills

Ausbildung

MD degree or equivalent

Tools

Medical Software

Jobbeschreibung

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(Senior) Director Safety Physician - ADC (m/f/x), Munich

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Job Category: Other

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EU work permit required: Yes

Job Reference:

1f062b20a8a4

Job Views:

1

Posted:

05.05.2025

Expiry Date:

19.06.2025

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 worldwide.

In Europe, we focus on two main areas: protecting people from cardiovascular disease and helping patients suffering from it to enjoy every precious moment, and becoming a global pharma innovator in Oncology with novel therapies for cancer.

Our European headquarters are in Munich, Germany, with affiliates in 13 European countries and Canada.

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

(Senior) Director Safety Physician - ADC (m/f/x)

The Position:

Responsible for the global safety strategy and risk management activities across the lifecycle for our oncology product portfolio, specifically Antibody Drug Conjugates (ADC).

Main focus is safety monitoring and risk management during the post-marketing phase, in accordance with regulations.

Collaborates with Global and EU Product Safety Leads, interfaces with high-level internal and external stakeholders, manages regulatory reports (RMPs, periodic reports), and leads proactive risk management initiatives.

• Engage and provide strategic input on post-marketing safety surveillance for oncology products.
• Drive safety strategy for lifecycle management of designated products.
• Lead development, maintenance, and submission of RMPs and PSURs.
• Participate in signal detection, safety analysis, and EU MAA activities, ensuring robust risk management.
• Oversee the effectiveness of risk management activities.
• Provide medical-scientific support for clinical trials, PASS, and NIS concerning pharmacovigilance.
• Manage responses to safety issues and collaborate on strategies with the safety team.
• Work with Clinical Safety and Pharmacovigilance management to align processes.
• Contribute to the Pharmacovigilance Quality Management System, including SOPs.

Professional Experience & Education:

• MD degree or equivalent; minimum 5 years of experience in hospital, university, CRO, or related fields; at least 3 years in pharmacovigilance.
• Knowledge of international legislation and guidelines on pharmacovigilance.
• Strong computer skills and proficiency in English.

Core Competencies:

• High reliability, accuracy, and strong communication skills.
• Analytical and systematic approach, ability to understand complex issues, and risk management.
• Interpersonal and negotiation skills, assertiveness, motivation, and cultural sensitivity.
• Team-oriented with good intercultural communication skills.

Why work with us?

At Daiichi Sankyo, you have the opportunity to make a difference and improve patients’ lives. We promote a culture of respect, learning, inclusion, and diversity. If you are proactive and passionate about patient needs, we look forward to your application.