Pharmacovigilance Quality Assurance Principal Scientist
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Pharmacovigilance Principal Scientist for global pharmaceutical brand. Responsibilities include QA oversight and compliance in drug safety and risk management processes.
Responsibilities:
- Support audits/inspections and contribute to CAPA development and resolution
- Manage PV deviations and CAPAs, including investigation, documentation, and timely closure
- Oversee the QMS with metrics, trend analysis, and risk indicators
- Provide PV vendor oversight, including risk‑based auditing and monitoring of third‑party performance
- Oversee Global Case Management PV vendor activities related to ICSR processing
- Provide QA oversight for end‑to‑end PV activities: case processing, safety surveillance, risk management, and signal detection
- Develop and implement global PV QA strategies and risk‑based audit programs aligned with FDA, EMA, MHRA, ICH, and other regulatory requirements
- Author, review, and maintain PV‑related SOPs, WIs, and quality documentation
- Collaborate cross‑functionally to ensure high‑quality, compliant documentation and processes
- Conduct root cause analyses and author deviations, investigations, and CAPAs
- Support trending analyses with third‑party vendors and internal stakeholders
- Track metrics and prepare presentations for client reporting
- Recommend and implement process improvements to prevent repeat issues
- Escalate PV operations issues to appropriate management
- Contribute to global PV operations process improvements and innovation initiatives
- Partner with PV service providers to design and monitor quality‑driven processes, supporting activities such as audits and performance reviews
- Support inspection and audit readiness, including documentation preparation and SME participation
- Ensure data integrity across safety systems, documentation repositories, and workflow platforms
- Manage workload effectively and coordinate cross‑functional deliverables using project management skills
Requirements:
- Degree in life sciences or medical related field or previous experience equating to educational requirements
- An advanced degree in strategy, innovation or leadership is an advantage
- Experience in operational risk assessment, quality issue management, CAPA development, and audit preparation
- Knowledge of PV vendor and contract management
- Familiarity with global PV regulations (FDA, EMA, ICH)
- Experience auditing PV vendors, CROs, or specialty pharmacies, including report writing and CAPA tracking
- Experience in clinical trial and post‑marketing PV
- Experience with SOP development, process review, and PV/clinical/regulatory documentation
- Experience with CAPA, RCA, and structured follow‑up plans
- Ability to map complex PV processes and manage document updates through quality systems
- Experience with PV systems such as Argus, ArisGlobal, or Veeva Vault Safety
Benefits:
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development
Similar Jobs
Doctor QA Specialist
Doctor QA Specialist ensuring quality patient communication for telehealth brands. Focused on quality assurance, compliance, and communication excellence across provider messaging.
Property Claims Quality Assurance Intern
Claims Quality Intern at California Fair Plan conducting research and vendor selection for claims review software. Collaborating with departments to enhance efficiency and accuracy in claims auditing.
Property Claims Quality Assurance Supervisor
Claims Quality Assurance Supervisor leading QA teams for property claims accuracy and compliance. Overseeing communications with the Department of Insurance and supporting Claims Examiners.
QA Analyst
QA Analyst ensuring software quality for innovative banking solutions at Stefanini. Managing testing processes and supervising external providers to uphold standards and documentation.
Quality Assurance Analyst – AI Data Annotation
QA Analyst responsible for quality auditing of AI/ML data annotation at Expedock. Collaborating with teams to improve data accuracy and provide feedback to annotators.
QA Engineer – Manual and Automation
Senior Quality Engineer responsible for designing automated test coverage for integration workflows. This role requires strong experience in Playwright and significant QA involvement in the healthcare sector.
Junior QA Engineer
Junior QA Engineer supporting testing of mobile applications for Virtusan. Handling functional, regression, and usability testing for iOS and Android devices.
Senior Supplier Quality Engineer
Supplier Quality Engineer responsible for overseeing supplier performance and compliance. Analyzing processes, ensuring quality standards, and collaborating with internal and external stakeholders.
QA Engineer
Manual QA Engineer ensuring product stability for a fintech SaaS company. Collaborating on product testing across frontend and backend systems to enhance quality.
Quality Engineering Technical Lead
Technical Lead in Quality Engineering, overseeing test strategy and automation in a global game services provider. Collaborate with teams to ensure high-quality standards across platforms.
Pentester
Pentester simulating attacks to identify vulnerabilities across networks and cloud infrastructure at Cyber Defence. Collaborating with teams to enhance client resilience and compliance.
Web QA Engineer
Web QA Engineer ensuring quality of a web-based photo editing product combining frontend and backend technologies. Validate UI and APIs with a focus on automation and efficiency.
Mobile Tester, iOS
Tester de aplicaciones móviles en Capgemini, desarrollando y ejecutando planes de prueba para sistemas Web/Digital. Validando integraciones y realizando pruebas transaccionales en plataformas iOS y Android.
Senior Quality Assurance Engineer
Senior QA Engineer responsible for QA processes and automation in IT projects for a fast-growing company. Collaborating with technical teams to improve product quality in various applications.
Quality Assurance Analyst – Co-op
QA Analyst Co-op for Real Estate Webmasters focused on software testing and product quality. Collaborating with a product team to ensure high standards in web applications.
Global Quality Assurance – Work-Study
Quality Assurance Intern for UPSA, participating in Global Quality activities and audits. Supporting compliance and documentation processes in the pharmaceutical field.
Quality Assurance Analyst
QA Analyst supporting Case Management Modernization Program at GDIT. Ensuring quality assurance for cloud-based data solutions across US federal courts with compliance testing.
Senior Quality Engineer
Sr. Quality Engineer I responsible for developing test automation frameworks at TrueML, a fintech company enhancing customer experiences for distressed borrowers.
Automation Tester
Automation Tester developing automated test scripts at Mind Computing. Ensuring software quality and functionality through analysis, execution, and collaboration.
Functional Tester
Functional Tester ensuring software quality and defect-free applications. Collaborating closely with developers and QA analysts, optimizing testing processes with latest tools and techniques.