Director of Patient Safety
Vor 3 Tagen
Job Title: Associate Director
Company: ageneo Life Science Experts (Interim Solutions) GmbH
Job Summary:
We are seeking an experienced Associate Director to join our team in a globally leading (bio)pharmaceutical company. The successful candidate 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:
- Crafting proactive, patient-centric Risk Management strategies tailored to designated compounds.
- Overseeing and executing all PV activities pertinent to assigned drugs, encompassing database setup, continual safety monitoring, and addressing safety concerns.
- Engaging in cross-functional collaboration with departments such as Clinical Development and Global Patient Engagement to devise patient-centric benefit-risk evaluations for developmental compounds.
- Collaborating with Global Epidemiology and Medical Affairs to design safety-oriented post-authorization studies.
- Analyzing clinical trial safety data for incorporation into clinical trial reports and regulatory submissions.
- Providing medical-scientific insights into regulatory documents, including PSURs, DSURs, RMPs, and Clinical Overview Statements.
- Keeping senior management apprised of the safety profile of designated drugs and suggesting 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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