Alphanumeric Systems

QA Engineer

• 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

Pharmacovigilance Quality Assurance Principal Scientist

Research Scientist

• Support Pharmacovigilance Management Systems for PV Operations.
• Contribute to all aspects of creation, maintenance, and achieving written standards for ICSR Management Team.
• Acts as a global PV Operations Leader for process discussions, including queries on strategy/policy related decisions; authors or provides significant input into the development of written standards.
• Support PV Scientists with enhancement of knowledge and skills for ICSR Management, regulatory submissions, and oversight duties.
• Work across a complex matrix environment to drive high-quality documentation of all processes and procedures to comply with internal standards and external regulatory requirements.
• Identify and assist in facilitating investigation into root cause and create corrective/preventative actions (CAPAs).
• Investigate and author deviations from established written procedures which include, root cause analysis (RCA), correction, corrective action and preventative action (CAPA) recommendations.
• Authoring investigations, RCA, CAPA for non-conformances from audit findings.
• Support trending analysis with third party service provider and clientGSK.
• Provide metrics for presentations.
• Recommend process changes to avoid repeat findings.
• Escalate identified problems or issues to the appropriate Management Personnel with PV Operations.
• Generate new ideas and proposals for global implementation; contribute to advancement of PV Operations methodology and processes.
• Work with third parties/vendors to assist in development and implementation of robust processes to support quality-driven organization and in agreement with ICSR Management Team written standards.
• Prioritize work and time management, in line with business needs.
• Partners with third parties and PV service providers/vendors to design, implement, and monitor robust, quality-driven processes aligned with ICSR Management Team standards; support oversight activities such as audits, quality checks, and performance reviews.
• Assist in inspection and audit readiness activities, including preparation of documentation, subject matter expertise during health authority inspections, and follow-up on inspection observations.
• Support data integrity initiatives by ensuring consistent application of standards across safety systems, documentation repositories, and workflow platforms.
• Manage workload and priorities effectively to meet business needs, timelines, and evolving regulatory expectations; utilize project management skills to coordinate cross-functional deliverables.

Pharmacovigilance Quality Assurance Principal Scientist

Pharmacovigilance Principal Scientist