What are the responsibilities and job description for the Senior Manager - Compliance and Drug Safety and Pharmacovigilance Operations position at The Fountain Group?
- Pay: 103.34/hr.
- Length of Assignment: 1 year assignment.
- Par time role. 10 - 20 hours / week, up to 25 hours per week as needed.
- Remote candidate semi local to Cambridge, MA. Must be able to attend onsite meetings as needed (rarely).
- Reporting to the Senior Director of Drug Safety and Pharmacovigilance Operations, will be responsible for supporting the operational delivery of the PV Quality system, inspection program, promotes operational and compliance excellence, and for ensuring PV activities follow regulatory requirements and corporate and departmental procedures. This position requires ability to influence and partner with internal and external colleagues and with senior management.
- Complete and assist with the oversight of the monitoring and control systems for supporting the PV System and PV Quality System, including Manage Pharmacovigilance System Master File.
- Subject matter expertise on all aspects of safety operations and overall data quality during audits/inspections.
- Development, reporting, and trending of metrics associated with PV Key Performance Indicators (KPI) to DSPV Leadership of the PV Quality System.
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