10 months ago
Our client is a global biopharmaceutical company who are focusing their efforts in developing products in both oncology and endocrinology. They are currently looking to find an experienced Pharmacovigilance and GCP Senior Director, to lead out its Regulatory Compliance efforts at its Palo Alto location.
In this role, you will lead a team responsible for Good Clinical Practice and Pharmacovigilance Regulatory Compliance of Development Operations and Clinical Development. You will be responsible for also establishing and executing global GCP and PV processes, standards, and compliance monitoring systems.
You will also be held responsible for ensuring compliance with all Corporate policies, global regulations and guidelines and internal procedures within Development Operations and Global Pharmacovigilance. You will manage a team of 3 Compliance professionals and support the QA group on a global scale. This role will require national and global travel also.
Main responsibilities include:
- Collaborating with internal and external stakeholders to ensure appropriate GCP and Pharmacovigilance systems are implemented and maintained on a regular basis
- Provides expert compliance advice on GCP and Pharmacovigilance strategies, programs, processes, initiatives, and activities to help manage and mitigate risk.
- Reviewing and analyzing audit, inspection and CAPA data to identify compliance trends and areas of exposure related to GCP and Pharmacovigilance.
- Periodically reviewing existing Standard Operating Procedures relative to Clinical Development, Development Operations and the Pharmacovigilance function within the business to determine the need for changes and updates of existing documents and the initiation of new procedural documents.
- To lead subject matter experts in the modification of current SOPs and in the initiation and development of new procedures.
- Identifies gaps and conducts non-compliance investigations.
- Performs impact assessment of changes in new GCP and Pharmacovigilance regulations and guidance on current practices and processes, makes recommendations for changes and coordinates with other functions for updates as needed.
- Partners with the Global Quality Assurance team to determine GCP and Pharmacovigilance best practices and to drive implementation of GCP and Pharmacovigilance standards across the Global organization.
- Bachelor of Science Degree required.
- Master’s degree in a scientific discipline is highly desirable.
- 10+ years’ worth of experience in quality systems, establishing and tracking metrics, compliance monitoring, and the development and maintenance of SOPs and training programs.
- 15+ years’ worth of experience in the pharmaceutical industry with significant experience in GCP and/or Pharmacovigilance.
- Prior management experience is required.
If this opportunity interests you, please get in touch today so that we can provide a full job description and explore in more detail!