Director - (Senior) Patient Safety Physician (gn) : Oncology

ageneo Life Science Experts (Interim Solutions) GmbH; Stuttgart; Vor Ort; EUR 90.000 - 150.000; Vollzeit

Zusammenfassung

An innovative firm is seeking a Director of Patient Safety in Oncology to lead global initiatives in pharmacovigilance and risk management. This role demands a medical degree and offers the opportunity to shape patient-centric strategies while collaborating with clinical development and regulatory teams. The ideal candidate will possess strong knowledge of PV regulations and excellent communication skills, ensuring a high impact on new drug development in a dynamic, global environment. Join a forward-thinking organization that values quality and patient safety.

Qualifikationen

• Medical degree with clinical and/or clinical research experience.
• Strong knowledge of pharmacovigilance and PV regulations.

Aufgaben

• Leading global initiatives for Patient Safety and Pharmacovigilance.
• Managing all PV activities for assigned drugs.

Kenntnisse

Pharmacovigilance

Risk Management

Clinical Development

Regulatory Submissions

Oncology Knowledge

Interpersonal Skills

Communication Skills

Ethical Standards

Ausbildung

Medical Degree

Jobbeschreibung

Job Description: Director Patient Safety (gn) - Oncology

We are recruiting for a globally leading (bio)pharmaceutical company to fill the position of Director Patient Safety (gn) in the therapeutic area of Oncology.

Responsibilities include:

1. Leading global initiatives for Patient Safety and Pharmacovigilance (PSPV) and Risk Management (RM) related to compounds at various development stages.
2. Collaborating closely with the clinical development department in a strategic and global capacity.
3. Developing proactive, patient-centric RM strategies for designated compounds.
4. Managing all PV activities for assigned drugs, including database setup, safety monitoring, and safety issue resolution.
5. Working with departments such as Clinical Development and Global Patient Engagement to create benefit-risk evaluations.
6. Partnering with Global Epidemiology and Medical Affairs for designing post-authorization safety studies.
7. Analyzing clinical trial safety data for reports and regulatory submissions.
8. Providing medical and scientific insights for regulatory documents like PSURs, DSURs, RMPs, and Clinical Overviews.
9. Chairing multidisciplinary Benefit Risk Teams.
10. Updating senior management on the safety profile and recommending PV/RM actions.

Candidate Profile:

1. Medical degree with clinical and/or clinical research experience.
2. Strong knowledge of pharmacovigilance and PV regulations in major markets.
3. Experience in clinical development and regulatory submissions is advantageous.
4. Deep understanding of the pharmaceutical industry and trends in pharmacovigilance.
5. Practical knowledge of PV regulations and compliance requirements.
6. Experience or background in oncology is a plus.
7. Excellent interpersonal and communication skills.
8. Strong ethical standards with a focus on quality and patient safety.
9. Fluent in English, both written and spoken.
10. Role involves strategic development and high impact on new drug development.
11. Operates within a global and intercultural work environment.