Director, Business and Process Optimization (Pharmacovigilance)

Ergomed; United States; Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health insurance

Bonus potential

Job summary

Ergomed seeks a Director, Business and Process Optimization to provide strategic leadership over operations and resourcing within a complex cross-functional environment. You will drive continuous process improvement, optimize processes and systems, and guide training and communications to achieve business goals.

You will lead large, cross-functional process initiatives, collaborate with senior leaders to implement strategic plans, and oversee staff, budgets and performance while driving internal

Qualifications

• Extensive leadership in PV and cross-functional teams.
• Proven track record with process improvement initiatives.
• Experience integrating compliance and training across systems.

Responsibilities

• Provides management and strategic direction to the business operation/corporate function.
• Leads development and execution of strategic business plans with senior leadership.
• Oversees cross-functional initiatives delivering insights and recommendations.
• Acts as transformation consultant for M&A integration activities.
• Oversees staffing, budgeting, scheduling and long-term planning.
• Promotes continuous process improvement and compliance across systems.

Skills

Leadership

Strategic planning

Cross-functional collaboration

Pharmacovigilance

Process improvement

Lean Six Sigma

Education

Life science degree

Pharmacy/Pharmacovigilance background

Tools

PV systems

Job description

The Director, Business and Process Optimization serves as a key member of the leadershipteam, providing strategic leadership in the direction and execution of the operations and resourcingfor the department in a complex cross-functional environment to develop and execute strategies thatensure continuous process improvement and optimize organizational performance, processes, andassociated systems, training and communications in order to achieve business goals and objectives.

ROLE AND RESPONSIBILITIES

• Provides management & strategic direction to the business operation/corporate function.
• Participates with senior leadership in developing and authorizing the implementationofstrategic business plans.
• Oversees a portfolio of cross-functional activities, projects and initiatives delivering strategicinsights, analyses and recommendations to drive continuous process improvement and assesscompliance with cross-functional processes and associated systems/applications, training andcommunications.
• Serves as business lead for large, complex, cross-functional process improvement initiatives.
• Collaborates, innovates and consults with multiple stakeholders, peers and leaders to drivestrategy, execution and communications planning to achieve continuous processimprovement and departmental and organizational business imperatives, goals andobjectives
• Oversees initiatives to develop, optimize, improve and assess compliance with cross functional processes and associated systems/applications, training and communications.
• Provides administrative oversight of the department, including staffing, budgeting, schedulingand long term planning. Provides strategic direction to staff through line management of ateam. Accountable for effective recruitment, induction, talent development and retention ofstaff. Provides ongoing coaching and feedback including formal performance appraisals,development plans and career coaching.
• Develops and implements business plans, forecasting and proactively supports and drivesprocess and systems optimization activities.
• May provide oversight and/or responses for client or internal process audits on processes,systems, or procedures and/or CAPAs.
• Cultivates an environment of continuous improvement
• Acts as an internal transformation consultant in overseeing M&A integration activities
• Life science graduate, pharmacy, nursing, other healthcare relatedqualification or experience in pharmacovigilance
• Extensivepharmacovigilance experiencewith experience of process improvement, safety applicationsand systems including demonstratedlinemanagement experience
• Extensive leadership experience in PV from a service providerenvironment
• Experience optimizing processes and managing through toimplementation
• Outstanding leadership and management skills
• Advanced skill in process development and improvement,especially as it applies to clinical and post-marketing PV
• Excellent project management skills
• Certification in process improvement methodologies such asLean Six Sigma is a plus
• Superior attention to detail, investigative and analytical skills
• Outstanding interpersonal, negotiation and problem solving skills
• Superior computer skills, to include an effectiveunderstanding of clinical management and pharmacovigilancetechnology andsystems
• Expert understanding of the practices, processes andrequirements of clinical trials, to include regulatory guidelinesand directives
• Superior oral and written communication skills including the ability to communicate in English, both orally and in writing
• Capable of directing and promoting teamwork in a multidisciplinary and/or multi-cultural team setting
• Capable of driving innovation in developing new ideas relatedto process improvements
• Outstanding organizational, judgment, analytical, decision making and interpersonal skills to manage complex projects inparallel and manage rapidly changing priorities

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.
• Integrity and trust: we do the right thing, especially when it is hard.
• Drive and passion: we care about the outcome, because someone is waiting on it.
• Agility and responsiveness: we move quickly, because patients cannot wait.
• Belonging: everyone is welcome, and every voice counts.
• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.

Medicine moves forward here. So will you.

At PrimeVigilance, …