Director, Business and Process Optimization (Pharmacovigilance)

PrimeVigilance

About The Position

The Director, Business and Process Optimization serves as a key member of the leadership team, providing strategic leadership for departmental operations and resourcing in a complex cross-functional environment. The role develops and executes strategies to drive continuous process improvement and optimize organizational performance, processes, systems, training, and communications in support of business goals and objectives. The position provides management and strategic direction to business operations, leads cross-functional process-improvement initiatives, and supports strategic planning with senior leadership. It also oversees departmental staffing, budgeting, scheduling, and long-term planning, while leading staff development, performance management, recruitment, and retention. The Director develops business plans and forecasts, supports process and systems optimization, and may oversee responses to client or internal audits and CAPAs. The role also serves as an internal transformation consultant for M&A integration activities.

Requirements

Life science graduate, pharmacy, nursing, or another healthcare-related qualification, or experience in pharmacovigilance.
Extensive pharmacovigilance experience, including process improvement, safety applications and systems, and demonstrated line management experience.
Extensive pharmacovigilance leadership experience in a service-provider environment.
Experience optimizing processes and managing them through implementation.
Outstanding leadership and management skills.
Advanced skills in process development and improvement, especially in clinical and post-marketing pharmacovigilance.
Excellent project management skills.
Superior attention to detail and investigative and analytical skills.
Outstanding interpersonal, negotiation, and problem-solving skills.
Superior computer skills, including an effective understanding of clinical management and pharmacovigilance technology and systems.
Expert understanding of clinical-trial practices, processes, and requirements, including regulatory guidelines and directives.
Superior oral and written communication skills, including the ability to communicate in English.
Ability to direct and promote teamwork in a multidisciplinary and/or multicultural team setting.
Ability to drive innovation and develop new ideas related to process improvements.
Outstanding organizational, judgment, analytical, decision-making, and interpersonal skills to manage complex projects in parallel and rapidly changing priorities.

Nice To Haves

Certification in process-improvement methodologies such as Lean Six Sigma.

Responsibilities

Provide management and strategic direction to the business operation or corporate function.
Participate with senior leadership in developing and authorizing strategic business plans.
Oversee a portfolio of cross-functional activities, projects, and initiatives, providing strategic insights, analyses, and recommendations to drive continuous process improvement and assess compliance.
Serve as the business lead for large, complex, cross-functional process-improvement initiatives.
Collaborate and consult with stakeholders, peers, and leaders to drive strategy, execution, and communications planning in support of organizational objectives.
Oversee initiatives to develop, optimize, and improve cross-functional processes and associated systems, applications, training, and communications, and assess compliance with them.
Provide administrative oversight of the department, including staffing, budgeting, scheduling, and long-term planning.
Provide strategic direction to staff through line management of a team.
Lead effective recruitment, induction, talent development, and staff retention.
Provide ongoing coaching and feedback, including formal performance appraisals, development plans, and career coaching.
Develop and implement business plans and forecasts, and proactively support and drive process and systems optimization.
Provide oversight of or responses to client or internal process audits involving processes, systems, procedures, or CAPAs, as needed.
Cultivate an environment of continuous improvement.
Act as an internal transformation consultant overseeing M&A integration activities.