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Pharmacovigilance Lead

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role ensures continuous improvement of processes, systems, and compliance across key PV activities.
It also supports inspection readiness, PSMF management, and partner oversight, requiring strong PV and regulatory expertise.

Main Responsibilities:

  • Lead transformation projects to drive innovation and excellence across Global Pharmacovigilance (GPV).
  • Deliver short- and mid-term initiatives, ensuring effective implementation of outcomes (process and SOP improvements).
  • Drive capability-building initiatives, including development of methodologies, tools, and frameworks.
  • Manage projects end-to-end, including planning, tracking milestones, and stakeholder communication.
  • Support and enhance GPV infrastructure, including procedures, data flows, tools, and documentation.
  • Collaborate with IT to advance digital solutions, automation, workflow optimization, and AI integration.
  • Ensure compliance across key PV activities, including case processing, safety systems, and local operations.
  • Contribute to PSMF maintenance, inspection readiness (CAPA, deviations), and partner management.

Requirements

Job Skills

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Benefit-Risk Excellence Lead

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role combines scientific expertise with innovation, shaping how safety data is assessed, interpreted, and communicated across a global environment. Ideal for a strategic thinker passionate about advancing signal detection, safety writing, and AI-enabled transformation.

Main Responsibilities:

  • Drive initiatives to enhance Benefit–Risk Assessment & Management (BRAM) practices, tools, and processes
  • Lead and deliver capability-building and transformation projects, from planning to implementation
  • Manage project timelines, milestones, and stakeholder communication
  • Oversee daily activities across signal detection and safety writing workflows (processes, tools, data, documentation)
  • Support continuous improvement of BRAM infrastructure and ensure regulatory compliance
  • Implement process and SOP updates within safety and signal detection systems
  • Collaborate with IT to advance digital transformation (automation, workflow optimisation, AI integration)
  • Apply strong expertise in signal detection and safety writing to ensure high-quality outputs

Requirements

Job Skills

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