Director, Business and Process Optimization (Pharmacovigilance)

About the role

PrimeVigilance, a global pharmacovigilance specialist, is looking for a Director, Business and Process Optimization. The role sits within the leadership team and provides strategic direction for the operations and resourcing of the department in a complex cross-functional environment. Its aim is to drive continuous process improvement and optimize performance, processes, systems, training and communications so that business goals are met.

Key responsibilities

• Provide management and strategic direction to the business operation and participate with senior leadership in developing and authorizing strategic business plans.
• Oversee a portfolio of cross-functional activities, projects and initiatives, delivering insights, analyses and recommendations and assessing compliance with processes, systems, training and communications.
• Serve as business lead for large, complex cross-functional process improvement initiatives and advise stakeholders on strategy, execution and communications.
• Administer the department, including staffing, budgeting, scheduling and long-term planning, and coach staff through line management, including recruitment, performance appraisals and development plans.
• Develop and implement business plans and forecasts, and drive process and systems optimization; oversee or respond to client and internal process audits and CAPAs.
• Cultivate continuous improvement and act as an internal transformation consultant on M&A integration activities.

Required profile

• Life sciences graduate, pharmacy, nursing or other healthcare qualification, or pharmacovigilance experience.
• Extensive pharmacovigilance experience with process improvement, safety applications and systems, including demonstrated line management experience.
• Extensive leadership experience in PV from a service provider environment, and experience optimizing processes and managing them through to implementation.
• Ability to direct and promote teamwork in a multidisciplinary and/or multi-cultural team.

Required skills

• Advanced process development and improvement, especially for clinical and post-marketing PV.
• Excellent project management skills; certification in process improvement methodologies such as Lean Six Sigma is a plus.
• Expert knowledge of clinical trial practices, processes and regulatory guidelines, and of clinical management and PV technology and systems.
• Superior oral and written communication in English, and strong analytical, negotiation and decision-making skills.