Global Safety Case Manager

4 days ago

Zagreb, Croatia beBeeLeadership Full time
Senior Operations Leader - Pharmacovigilance

The role is responsible for the end-to-end execution of global ICSR operational activities, ensuring full compliance with internal procedures and regulatory requirements. Reporting to the Head of Systems Data Innovation (SDI), this member of the global SDI leadership team will lead a high-performing global team, driving continuous improvement across the ICSR lifecycle.


Key Responsibilities:
  • Execution and monitoring of ICSR processes to ensure operational efficiency, quality, and adherence to industry standards.
  • Developing robust real-time monitoring and forecasting models to support seamless execution and enhance case processing KPIs.
  • Championing innovation and leveraging advanced technologies such as automation, bots, and AI to drive efficiency and scalability.
  • Leading cross-functional initiatives to drive alignment and best-practice adoption.
  • Providing strategic insights and data to PV core leadership to support decision-making and long-term planning.

Requirements:
  • Minimum Master's degree in Life Sciences or another related field.
  • Minimum of 10 years of experience in pharmacovigilance with strong knowledge of ICSR lifecycle and regulatory requirements.
  • Minimum of 5 years of managing global teams and complex projects.
  • Experience in inspections/audits and readiness activities is a strong advantage.
  • Fluent in English.

What You'll Get:

Opportunity to shape and implement strategies in partnership with key stakeholders.

Cross-functional collaboration and exposure to various aspects of the business.

Professional growth and development opportunities.


Location:

Remote work options available. Must be able to travel occasionally.

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