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 lead son inspection preparedness
- Support offices in inspection readiness in person (US-Boston area and Global travel)
- Nursing or PharmD
Pharmacovigilance Quality Assurance Project Lead
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. Strong project management and vendor quality skills. Understands and interprets regulatory requirements...
Pharmacovigilance Quality Assurance Project Lead
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. Strong project management and vendor quality skills. Understands and interprets regulatory requirements...
Lead Analyst, Compliance Quality Assurance
As the Lead Quality Analyst, Quality Control & Assurance you will join a Scaled Services team of 14 brilliant and driven professionals. You will be responsible for assisting the Manager, Compliance Quality Control and Assurance in overseeing the completion of quality reviews, contributing to the gro...
Director, Clinical Quality Assurance, Pharmacovigilance
The Director of CQA-PV is the supervisor of the Clinical Quality Assurance Department with responsibilities for quality oversight of the Post Marketing Good Pharmacovigilance Practices (GPvP) and Commercial Operations that contribute to the PM PV safety data. Provide quality assurance and compliance...
Quality Assurance Lead
Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. Experience with quality assurance for specialized de...
Lead Project Manager, Strategic Quality and Safety Initiatives | Dana-Farber Cancer Institute
Under the direction of the Administrative Director for Quality and Patient Safety Operations, the Lead Project Manager for Strategic Quality and Safety Initiatives will provide team oversight and expert project management to a portfolio of cross-functional priorities that support the department???s ...
Automation Test Lead
API testing Functional and using Rest Assured or similar libraries, SQL knowledge Selenium with BDD - Cucumber and Testing or similar testing framework. Lead the development and execution of comprehensive test plans and test cases. Show proficiency in test automation and performance testing. We brin...
Quality Assurance & Communications Specialist
Participate in the preparation and review of quality reports to be used for employee metrics; contribute to quality assurance processes to ensure written guest correspondence is consistently meeting department quality standards. Quality Assurance & Communications Specialist. This position is primari...
Manager, Supplier Quality Assurance
Minimum of 7-10 years quality assurance / supplier quality engineering experience in a. Monitor supplier quality events utilizing the Lantheus Quality System, as appropriate. Plans, organizes, directs and reports on quality activities to assure external partners and suppliers meet or exceed Lantheus...
Business Analyst/ QA with Salesforce
BA 2) 2+ years of QA experience 3) Proficiency with Salesforce (system configuration, admin, and reporting) 4) Public Sector experience (WILL NOT CONSIDER CANDIDATES WITHOUT IT). Our Housing Stabilization Team is looking for an experienced Business Analyst to support the emergency housing assistance...