Pharmacovigilance Quality Assurance Project Lead

Responsibilities:PVQA Project leader consultant is responsible for the development and oversight of execution of the global PV QA audit strategy, inspection readiness, vendor oversight and metrics driven strategy.Partners with affiliates to provide guidance when needed related to regulatory compliance and will engage with them to support process improvements, including SOP needs.Understands and interprets regulatory requirements and guidance related to Good Pharmacovigilance Practices (GVP) on a global level, not just in the US.Is responsible for communicating audit results to QA and internal customers while supporting the PV functions with CAPA development, KPI's, SOPS, Process improvements, etc.Requirements:Have knowledge and experience necessary to develop the annual global audit plan for internal PV and external vendors related to PSRM.Ability to analyze PV related QA audit results and operational data to identify trends and suggest improvements.Contribute to pharmacovigilance safety and efficacy data review and interpretation.Collaborating with cross-functional teams ensure that key study milestones are met.CAPA lead for global PSRM.Strong project management and vendor quality skills.Advanced knowledge and understanding of drug development and both the Good Clinical Practice (GCP) and GVP regulatory requirements.Strong communication skills and ability to articulate QA strategy to internal and external stakeholders.Develop a QMS for PSRM (previous experience using quality management system software to manage QMS required).Oversee the Argus database and retrospective quality reviews of cases.Train other office safety leads on inspection preparedness.Support offices in inspection readiness in person (US-Boston area and Global travel).Nursing or PharmD.

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