Job Description

Reporting to the Senior Director of Drug Safety and Pharmacovigilance Operations, the Senior Manager, Contractor, of Compliance and DSPV Operations is 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.
• Partner with Quality and relevant stakeholders with the generation, review, and approval of governing documents, such as SOPs, Operating Guidelines and Safety Management Plans, as necessary, and ensure operational implementation, regulatory requirements and commitments, and important industry guidelines are considered (e.g. ICH guidelines and CIOMS working group).
• Maintenance of the training programs with Quality for DSPV Staff and vendors.
• Provide functional support & input to set up or manage vendor relationships (e.g., contract details, safety management plans).
• Liaisons with Quality and assists with managing the inspection readiness for DSPV including but not limited to organizing the DSPV function and engaging with relevant stakeholders and functions to ensure worldwide inspection readiness for clinical and post marketing inspections, responses are reviewed and approved internally by relevant stakeholders.
• Monitor compliance with Safety Data Exchange Agreement with partners, as required.
• Monitor timely submission of expedited safety reports and other external submissions through effective vendor management and performance metrics review.
• Partner with QA and maintain overall department oversight of DSPV’s internal and vendor investigations, deviations, CAPA management, and effectiveness checks.
• Assists with the Oversight of the management and archival of DSPV Records/documentation.
• Other responsibilities as required.

• Ability to work independently and productively and set priorities across multiple projects with little supervision.
• Ability to promote team collaboration, fosters open dialog, maintains an inclusive collaborative environment, keeps a team focused on a common goal and maintains positive momentum through difficulties.
• Prior PV Operations experience including case processing and reporting of clinical trial and post marketing reports
• Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
• Good knowledge of FDA and EU legislation and ICH PV guidelines.
• Prior NDA / MAA experience preferred.
• Strong analytical and problem-solving skills with superb attention to detail.
• Strong verbal, written technical communication and presentation skills

• Minimum of bachelor’s level degree in nursing, pharmacy, or other health care related profession or life sciences or in science and engineering required.
• Master’s or Doctorate level degree in health care related profession preferred but not essential

• Minimum 5 years in Drug Safety/Pharmacovigilance in pharmaceutical industry setting with prior experience in PV Compliance.
• Minimum 3-5 years’ experience working with CROs, vendors, and relationship management preferred.
• Experience in GCP/GVP regulation and guidelines, including but not limited to US FDA, EU, ICH Guidelines and CIOMS working group reports.
• Experience with regulatory inspections and company audits including USA/MHRA/EMA PV inspections.

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