Quality and Training Specialist – Pharmacovigilance

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🕒 June 12

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Ensure PV project teams are fully equipped with skills and quality oversight • Design and deliver training programs for PV project teams • Conduct real-time quality analysis of project deliverables • Maintain and update SOPs, work instructions, and client procedural documents • Support development and reporting of PV compliance metrics • Lead escalation and cross-functional process improvement activities related to GPV quality issues • Ensure readiness for PV audits and inspections • Serve as the primary contact for PV-related quality assurance matters • Present quality trends and recommendations to stakeholders • Mentor and train colleagues, collaborating with cross-functional teams, CROs, and vendors

🎯 Requirements

• 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 • 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 • Ability to manage complex projects and lead training initiatives • Experience with electronic systems used in regulated environments (drug safety, LMS, documentation management)

🏖️ Benefits

• Reasonable accommodation for individuals with disabilities • Equal Opportunity Employer • Professional development opportunities