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Associate Director
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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 organization, you will play a critical role in ensuring the safety and efficacy of our pharmaceutical products.
Key Responsibilities:
- Develop and Implement Patient Safety Strategies: Craft proactive, patient-centric risk management strategies tailored to designated compounds, ensuring compliance with regulatory requirements.
- Oversee Pharmacovigilance Activities: Execute all PV activities pertinent to assigned drugs, including database setup, continual safety monitoring, and addressing safety concerns.
- Collaborate with Cross-Functional Teams: Work closely with Clinical Development, Global Patient Engagement, and Medical Affairs to devise patient-centric benefit-risk evaluations for developmental compounds.
- Design and Analyze Safety-Oriented Studies: Collaborate with Global Epidemiology to design safety-oriented post-authorization studies and analyze clinical trial safety data for incorporation into clinical trial reports and regulatory submissions.
- Provide Medical-Scientific Insights: Provide medical-scientific insights into regulatory documents, including PSURs, DSURs, RMPs, and Clinical Overview Statements.
- Communicate Safety Profiles: Keep senior management apprised of the safety profile of designated drugs and suggest PV/RM actions.
Requirements:
- Medical Degree and Clinical Experience: Medical degree with clinical and/or clinical research experience.
- Pharmacovigilance Expertise: Proficient knowledge in pharmacovigilance (PV) and a comprehensive understanding of PV regulations in major markets.
- Clinical Development Experience: Experience in clinical development and involvement in regulatory submissions would be advantageous.
- Therapeutic Area Expertise: Clinical or research experience in the therapeutic area CMR are a big plus.
- Interpersonal and Communication Skills: Strong interpersonal and communication skills.
- Strong Ethical Sense: Strong ethical sense coupled with a focus on quality and patient safety.
- Language Skills: Excellent English language skills, both written and verbal.
What We Offer:
- Strategic Role: Highly strategic and development-related role.
- Impact on Drug Development: High-impact on the development of new drugs.
- Global Work Environment: Global and intercultural work environment.
