Director, Business and Process Optimization (Pharmacovigilance)

About the role

Ergomed is hiring a Director, Business and Process Optimization (Pharmacovigilance) in Zagreb. The role is a key member of the leadership team, providing strategic direction for the operations and resourcing of the department in a complex cross-functional environment. The aim is to develop and run strategies that ensure continuous process improvement and optimize performance, processes, systems, training and communications.

Key responsibilities

• Provide management and strategic direction to the business operation and corporate function, and take part in developing and authorizing strategic business plans.
• Oversee a portfolio of cross-functional activities, projects and initiatives, and serve as business lead for large, complex process improvement initiatives.
• Collaborate with stakeholders, peers and leaders to plan strategy, execution and communications.
• Administer the department, including staffing, budgeting, scheduling and long-term planning, and line-manage a team with recruitment, induction, talent development and retention.
• Coach staff, give feedback, run formal performance appraisals, development plans and career coaching.
• Develop and implement business plans, forecasts and process and systems optimization activities.
• Oversee or respond to client or internal process audits, systems, procedures and CAPAs.
• Cultivate continuous improvement, act as an internal transformation consultant on M&A integration, and drive innovation in process improvements.

Required profile

• Life sciences graduate, pharmacy, nursing or other healthcare qualification, or pharmacovigilance experience.
• Extensive pharmacovigilance experience, including process improvement, safety applications and systems, with demonstrated line management experience.
• Extensive leadership experience in PV from a service provider environment, and experience optimizing processes through to implementation.
• Excellent project management skills; certification in Lean Six Sigma is a plus.

Required skills

• Advanced process development and improvement, especially for clinical and post-marketing PV.
• Expert knowledge of clinical trial practices, processes and regulatory requirements.
• Strong analytical, investigative and communication skills, with English spoken and written.
• Ability to lead in multidisciplinary, multicultural teams and manage parallel projects.