Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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 Good 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) experience.
- 5+ years in PV quality roles supporting audits, inspections, and GPV compliance activities.
- Experience developing quality systems, managing risk-based PV audit programs, and implementing process improvements. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, and Abilities:
- Strong knowledge of global GPV regulations (FDA, ICH, CDSCO-PvPI, EU GVP; PMDA preferred).
- Expertise in audits/inspections and development of responses.
- Advanced understanding of QMS, process improvement, and quality governance.
- Strong communication, presentation, and stakeholder management skills.
- Ability to manage complex projects and lead training initiatives.
- Experience with electronic systems used in regulated environments (drug safety, LMS, documentation management).