Safety Systems Manager

il y a 2 semaines


Paris, Île-de-France VCLS Temps plein

Safety Systems Manager Job Description

VCLS is seeking a highly skilled and experienced Safety Systems Manager to oversee the safety systems, processes, and technologies within our organization. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and driving continuous improvement in safety management.

Key Responsibilities:

  • Implement and Maintain Safety Systems: Oversee the development, implementation, and maintenance of safety systems and processes, including pharmacovigilance systems, safety databases, and signal detection tools.
  • Ensure Regulatory Compliance: Ensure that all safety systems and processes are compliant with regulatory requirements, guidelines, and best practices related to safety systems and pharmacovigilance.
  • Lead Safety Data Exchange: Lead the development and implementation of safety data exchange agreements with external partners, ensuring seamless data sharing and collaboration.
  • Collaborate with Cross-Functional Teams: Collaborate with cross-functional teams to identify and evaluate safety signals and risks, providing expert guidance and support to project teams.
  • Manage Safety System Vendors: Manage safety system vendors and contractors, ensuring timely delivery of services and adherence to quality standards.
  • Lead Safety System Audits: Lead and participate in safety system audits and inspections, ensuring compliance with regulatory requirements and industry standards.
  • Monitor Safety System Performance: Monitor and report on key safety system performance indicators and metrics, identifying areas for improvement and implementing corrective actions.
  • Stay Up-to-Date with Industry Trends: Stay current with industry trends and advancements in safety systems and pharmacovigilance, applying this knowledge to drive continuous improvement within our organization.

Requirements:

  • Education: Bachelor's or Master's degree in Life Sciences, Pharmacology, Pharmacy, or a related field.
  • Experience: Minimum of 5 years of experience in safety systems management or pharmacovigilance, with a strong understanding of safety systems and pharmacovigilance regulations and guidelines.
  • Skills: Excellent analytical and problem-solving skills, with the ability to work effectively in a cross-functional and global team environment.
  • Preferred Qualifications: Prior experience in managing safety system audits and inspections, with a strong understanding of drug safety processes and risk management principles.

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