Director of Pharmacovigilance and Drug Safety
2 weeks ago
Job Summary:
The Director of Pharmacovigilance and Drug Safety will serve as the lead for pharmacovigilance and drug safety initiatives at MoonLake Immunotherapeutics. This individual will be responsible for developing and implementing safety strategies for clinical development programs, ensuring compliance with regulatory requirements, and providing medical oversight for safety data activities.
Key Responsibilities:- Develop and Maintain Safety Strategies: Establish and maintain safety strategies for assigned projects and products, ensuring strong product knowledge and compliance with regulatory requirements.
- Regulatory Compliance: Ensure compliance with international pharmacovigilance requirements, including those in the UK, Europe, and US, and interact with regulatory authorities as needed.
- Safety Data Management: Oversee the collection, processing, and analysis of safety data, ensuring accuracy and completeness.
- Medical Oversight: Provide medical evaluation of Individual Case Safety Reports (ICSRs) and safety monitoring of global scientific/medical literature for assigned products.
- Regulatory Document Preparation: Lead the development of clinical safety and benefit-risk sections of regulatory documents and prepare for meetings with regulatory and public health authorities.
- Team Collaboration: Work closely with cross-functional development teams, including study teams, to ensure effective safety management.
- Training and Development: Provide safety-related training to company employees as needed.
- Education: Qualified Physician (GMC or GMC permissible).
- Experience: Foundational training and experience in clinical practice with a general medicine background, solid experience in clinical safety and pharmacovigilance, and expertise in preparing clinical safety assessments and regulatory reports/submissions.
- Skills and Knowledge: Strong knowledge of international pharmacovigilance requirements, safety databases, and global regulatory requirements for safety reporting and labeling.
MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company focused on unlocking the potential of sonelokimab, a novel investigational Nanobody for the treatment of inflammatory diseases. We are committed to revolutionizing outcomes for patients and making a meaningful impact in the field of immunotherapy.
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