Senior Pharmacovigilance Quality Assurance Director
1 week ago
The Senior Pharmacovigilance Quality Assurance Director is a critical member of the Clinical Quality Assurance team at Corcept Therapeutics. This role plays a key leadership position in ensuring the success of drug safety and pharmacovigilance processes, systems, training, and compliance programs for both development and marketed products.
Key Responsibilities:
- Lead quality operations and compliance activities to support the DSPV process, systems, training, and compliance programs
- Champion and influence management growth of the Clinical Quality Assurance team
- Serve as a QA representative and provide compliance advice and strategy
- Oversee pharmacovigilance quality management system (QMS) and ensure compliance with global regulatory requirements
- Work with Drug Safety and Pharmacovigilance, IT, and other departments to maintain safety database validation and compliance
- Perform gap assessments and develop audit plans using risk-based approaches
- Manage inspection readiness strategy and support inspection readiness activities
- Oversee regulatory audits and inspections, including sponsor inspections, post-marketing Adverse Drug Experience (PADE) inspections, and contract research organization (CRO) inspections
- Develop training programs for pharmacovigilance staff to ensure awareness and adherence to quality standards
- Conduct and/or manage qualification of DSPV service providers
- Lead non-compliance event investigations and CAPA implementation
- Maintain knowledge of agency and industry trends, standards, and methodologies related to GVPs and notify changes to applicable teams
Requirements:
- 10+ years of experience in pharmacovigilance, including 5 years in leadership or management roles
- Hands-on experience with safety database systems, including validation, audits, and compliance assessments
- In-depth knowledge of global pharmacovigilance regulations, guidelines (e.g., ICH, GVP, other GxP), and safety reporting requirements
Preferred Qualifications:
- Experience in audit and inspection management
- Exceptional communication skills
- Ability to perform GVP audits
- Advanced Microsoft application skills (Word, Excel, PowerPoint)
About the Role:
This is a headquarters-based position requiring on-site attendance three days a week. The pay range for this role is estimated to be between $218,400 - $256,900 based on geographic location, job-related knowledge, skills, experience, and education.
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