Strategic Patient Safety Physician
Vor 4 Tagen
Job Title: Associate Director Patient Safety Physician
About the Role:
We are seeking an experienced Associate Director Patient Safety Physician to join our team at ageneo Life Science Experts (Interim Solutions) GmbH. As a key member of our Patient Safety and Pharmacovigilance team, you will be responsible for orchestrating global initiatives for Patient Safety and Pharmacovigilance (PSPV) and Risk Management (RM) pertaining to compounds at various stages of development.
Key Responsibilities:
- Craft proactive, patient-centric Risk Management strategies tailored to designated compounds.
- Oversee and execute all PV activities pertinent to assigned drugs, encompassing database setup, continual safety monitoring, and addressing safety concerns.
- Engage in cross-functional collaboration with departments such as Clinical Development and Global Patient Engagement to devise patient-centric benefit-risk evaluations for developmental compounds.
- Collaborate with Global Epidemiology and Medical Affairs to design safety-oriented post-authorization studies.
- Analyze clinical trial safety data for incorporation into clinical trial reports and regulatory submissions.
- Provide medical-scientific insights into regulatory documents, including PSURs, DSURs, RMPs, and Clinical Overview Statements.
- Keep senior management apprised of the safety profile of designated drugs and suggest PV/RM actions.
Requirements:
- Medical degree with clinical and/or clinical research experience.
- Proficient knowledge in pharmacovigilance (PV) and a comprehensive understanding of PV regulations in major markets.
- Experience in clinical development and involvement in regulatory submissions would be advantageous.
- Clinical or research experience in the therapeutic area CMR are a big plus.
- Strong interpersonal and communication skills.
- Strong ethical sense coupled with a focus on quality and patient safety.
- Excellent English language skills, both written and verbal.
What We Offer:
- A highly strategic and development-related role.
- A high-impact on the development of new drugs.
- A global and intercultural work environment.
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