Director, Pharmacovigilance Operations Wilmington United States,
This position is responsible for creating, directing and managing the company?s infrastructure and staff to support the operational components of a quality Pharmacovigilance system including procedures for the accurate and timely processing, review and reporting of adverse events from investigational Incyte compounds and Incyte marketed products. In addition, this position must build and maintain relationships with key strategic internal and external stakeholders.
- Organize, direct and manage the process for identifying, evaluating, and selecting qualified and appropriate outsourcing vendors for safety data handling during Incyte-sponsored clinical studies and for marketed products
- Ensure that these vendors exchange the appropriate and quality safety data according to agreed timelines in conjunction with the Pharmacovigilance (PhV) Quality, Compliance and Safety Systems group.
- Oversee the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the ARGUS database to accommodate these trials and products.
- Define operational practices/procedures for efficient processing and reporting of serious adverse events from clinical trials, as well ensuring that the process also is consistent with the handling of adverse events from marketed sources
- Develop and maintain written procedures related to the processing and reporting of SAEs from clinical trials to ensure proactive surveillance of Incyte products during development
- Manage the planning and preparation of AE sections of protocols for Incyte studies, review of CRFs and presentations at investigator/CRO kick-off meetings
- Assist Medical Directors/Safety Physicians in the identification, analysis and reporting of safety information with Incyte compounds under development and products
- Participate in clinical study teams, representing the PhV department and/or mentoring direct reports in this role
- Ensure that the reconciliation of ARGUS safety data with groups and databases external to PhV occurs effectively, efficiently, on time, and in accordance with internal procedures
- Support the safety database platform and required upgrades, as well as the appropriate MedDRA dictionary upgrades
- Responsible of the management of adverse events reported during named patient use , in the post marketing setting, spontaneously or in the context of non-interventional studies, or of local cases registered from investigator sponsored trials (IST) or expanded access program in agreement with contract provisions.
- Assist in readiness for FDA inspections as well as playing a leading role in all activities to ensure readiness & proper management of FDA inspections.
- Prepares local periodic reports; submits these reports within the appropriate timelines according to national regulations in conjunction with regulatory affairs. Ensures submission, either directly or through CRO of periodic safety reports and any other reports (as applicable) which are prepared in accordance with the local regulations.
- Assist the Medical Information teams with procedures around AE collection and the authoring of local SOPs.
- Oversee submissions of expedited reports to the FDA & other health authorities
- Develop standard procedures and guidelines for PhV operations, which are integrated and fully aligned across all PhV sites in conjunction with the PhV Quality, Compliance and Safety Systems group.
- Develop efficient workflows in Argus in conjunction with the Global Drug Safety Systems and Quality Management team.
- Effectively utilizing case metrics to assess productivity, opportunities for workflow and quality improvement, and to measure effectiveness of change initiatives.
- Proactively lead case processing/ case quality improvement initiatives
- Fully support training of department personnel and other line functions involved in AE collection or processing such as Medical Affairs, sales, medical information, etc., in collaboration with PhV Quality, Compliance and Safety Systems group
- Supports safety physicians in the preparation of periodic reports (e.g. PBRER, PADER, DSUR) & other safety documents as required.
- Represents drug safety on project teams, other departments, and committees as needed.
- Bachelor?s degree in life sciences, pharmacy, nursing or equivalent health experience
- Minimum of 8 years of experience in Drug Safety / Pharmacovigilance role in pharmaceutical industry; minimum 5 years in managerial role in drug safety
- Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Drug Safety department
- Through knowledge and experience in all aspects of safety reporting for clinical trials and marketed situations.
- Ability to successfully prioritize and work on multiple tasks
- Effective verbal and written communications skills; must have demonstrated ability to write business processes in a clear, concise and accurate manner
- Strong interpersonal skills and demonstrated ability to manage, motivate and influence work behaviors of individuals who are not direct reports
- Strong knowledge about safety database structure, MedDRA and linked technologies
- Strong knowledge and experience with currently available drug safety database systems, document management systems and QC tool
- Operational expertise with ARGUS preferred.
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