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Thermo Fisher Scientific
Thermo Fisher Scientific
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Thermo Fisher Scientific develops and delivers technologies, laboratory products, and pharmaceutical services that support scientific research and healthcare. Its work spans life sciences research, analytical problem-solving, laboratory productivity, diagnostics, and the development and manufacturing of therapies. The company serves customers through a global team and a portfolio of brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. Its careers encompass the scientific, healthcare, manufacturing, logistics, and service operations behind these offerings.
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Remote Pharmacovigilance Quality Manager – Serbia

Lead pharmacovigilance quality systems, audits, training, and compliance for Global Patient Safety operations. The role supports remote work from Serbia and other listed European locations.

BGBulgariaESSpainGRGreeceHRCroatiaHUHungaryPTPortugalRSSerbiaRemoteFull-timeMiddleSeniorEnglish RequiredManager

Description

  • Run the Pharmacovigilance Quality Management System within Global Patient Safety.
  • Help expand the Global Patient Safety Quality Management function.
  • Maintain and deliver the comprehensive training program.
  • Oversee Global Patient Safety procedural documents.
  • Support audit and inspection readiness, coordination, and management.
  • Advance continuous improvement through issue management, process changes, and KPI development.
  • Support or manage GVP audits and inspections.
  • Prepare Global Patient Safety teams for inspections and keep supporting documents readily accessible.
  • Coordinate responses to audit and inspection findings.
  • Review issue trends and implement plans to address underlying causes.
  • Identify internal deviations and support corrective and preventive actions, including root-cause analysis.
  • Lead corrective and preventive action implementation with the client Quality function.
  • Develop, maintain, expand, and deliver pharmacovigilance training.
  • Help monitor and update Global Patient Safety training curricula.
  • Train relevant client staff and third parties when applicable.
  • Develop, review, and improve Global Patient Safety processes and procedures.
  • Take part in cross-functional procedural document work and forums.
  • Support document control in Veeva.
  • Help develop and assess key performance indicators.
  • Monitor third-party compliance with contractual obligations, PVAs, SDEAs, and other agreements.
  • Coordinate with the QA Department on Global Patient Safety quality and compliance needs and deliverables.
  • Monitor compliance with Global Patient Safety SOPs and controlled documents.
  • Carry out other duties assigned by the line manager or Global Patient Safety leadership.

Requirements

  • Bachelor’s degree at minimum in pharmacy, nursing, healthcare, another life-science or technical discipline, or a country-equivalent combination of education and experience.
  • At least five years of experience in the pharmaceutical or biotechnology industry.
  • At least three years of experience in pharmacovigilance or drug safety.
  • A strong record of managing pharmacovigilance quality systems, processes, and teams.
  • Experience preparing for, hosting, and responding to global audits and regulatory inspections.
  • Working knowledge of pharmacovigilance regulations and guidance in Europe, the United States, and Japan.
  • Knowledge of GxP quality and compliance requirements, processes, and measures.
  • Strong planning and organizational skills.
  • Excellent spoken and written communication.
  • Ability to work in a global environment.
  • Solution-focused approach, with the ability to prioritize and work independently.
  • Strong presentation skills and ability to explain complex issues clearly.
  • Demonstrated skill in authoring and contributing to procedural documents.
  • Ability to motivate and collaborate with multidisciplinary teams.
  • Proficiency with Microsoft Office and tracking databases.
  • Fluent written and spoken English.

Benefits

  • Fully remote work arrangement.

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