Manager/Senior Manager, Clinical and PV Quality
Axsome Therapeutics
Axsome Therapeutics seeks a Manager/Senior Manager for Clinical and Pharmacovigilance Quality to oversee GCP and GVP compliance across clinical trials and related processes. The role ensures adherence to FDA, EMA, Health Canada, MHRA regulations and ICH guidelines.
Responsibilities
- Provide GCP and GVP oversight of clinical trial activities and associated records
- Ensure quality and compliance with global regulatory standards and company processes
- Monitor adherence to ICH guidelines and applicable regulations
- Review and assess clinical trial documentation and procedures for compliance
Requirements
- Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) expertise
- Knowledge of FDA, EMA, Health Canada, and MHRA regulatory requirements
- Familiarity with ICH guidance documents (GCP E6, E2, and related standards)
- Experience developing or implementing standard operating procedures
- Quality assurance experience in clinical trial environments
Vacancy posted 2 days ago
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