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

Job Title: 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:

1. Lead global initiatives for Patient Safety and Pharmacovigilance (PSPV) and Risk Management (RM) related to compounds at various development stages.
2. Collaborate closely with the clinical development department and participate in strategic, global functions.
3. Develop proactive, patient-centric RM strategies tailored to specific compounds.
4. Oversee all PV activities for assigned drugs, including database setup, safety monitoring, and safety issue resolution.
5. Partner with Clinical Development and Global Patient Engagement to create benefit-risk evaluations for developmental compounds.
6. Coordinate with Global Epidemiology and Medical Affairs on safety-focused post-authorization studies.
7. Analyze clinical trial safety data for reports and regulatory submissions.
8. Contribute medical-scientific insights to regulatory documents such as PSURs, DSURs, RMPs, and Clinical Overviews.
9. Chair multidisciplinary Benefit-Risk Teams.
10. Keep senior management informed about the safety profiles of drugs and recommend PV/RM actions.

Candidate Profile:

• Medical degree with clinical and/or clinical research experience.
• Proficient in pharmacovigilance and familiar with PV regulations in major markets.
• Experience in clinical development and regulatory submissions is advantageous.
• Deep understanding of the pharmaceutical industry, PV trends, and developments.
• Practical knowledge of PV regulations and compliance requirements in key markets.
• Clinical or research experience in oncology is a significant plus.
• Strong interpersonal and communication skills.
• High ethical standards with a focus on quality and patient safety.
• Excellent English language skills, both written and verbal.
• Strategic mindset with a development-oriented approach.
• Ability to influence drug development processes on a global scale.
• Experience working in a multicultural and international environment.

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