The Quality and Training Specialist (QTS) plays a vital role in ensuring PV project teams are fully equipped with the skills, training, and quality oversight needed to meet high performance and compliance standards. This position is responsible for timely and effective training of project team members, real-time quality review of PV deliverables, audit and inspection support, maintenance of procedural documents, and continuous process improvement to ensure high-performing and compliant PV operations.
Design and deliver training programs to enhance PV project team capabilities, including onboarding and ongoing refresher training. Conduct real-time quality analysis of project deliverables, including trend analysis, gap assessments, and corrective training. Maintain, update, and review SOPs, work instructions, project-specific guidelines, and client procedural documents to ensure compliance and consistency. Support development and reporting of PV compliance metrics aligned with Positive Pharmacovigilance Practice (GPV).



Lead escalation and cross-functional process improvement activities related to GPV quality issues. Ensure readiness for PV audits and inspections; actively support internal/external audits and post-inspection follow-up actions. Serve as the primary contact for PV-related quality assurance matters across assigned projects. Present quality trends, issues, and recommendations to internal stakeholders and client partners. Develop, maintain, and ensure effectiveness of SOPs, protocols, guidance documents, training plans, and compliance materials. Mentor and train colleagues; collaborate with cross-functional teams, CROs, and vendors to ensure alignment and execution of project-specific standards. Stay current with global PV/clinical/technology trends and incorporate best practices into training and quality management strategies.\ Education and Experience:
Bachelor’s or Master’s degree in Pharmacy or Life Sciences. 7+ years of relevant Pharmacovigilance (PV) ex

📌 Quality and Training Specialist-Pharmacovigilance (India)
🏢 Thermo Fisher Scientific
📍 India