Job Description

Job Description

Director, Global Patient Safety Operations

The Opportunity:

We are seeking a highly skilled and experienced Director of Global Patient Safety (GPS) Operations to join our dynamic team. The Director of GPS Operations will be responsible for developing and scaling the pharmacovigilance operations infrastructure that supports growth and increased portfolio complexity. This position offers the opportunity to build upon an established team and function by implementing the systems, processes, and practices required for long-term scalability and compliance.

Reporting to the Executive Director of GPS Operations, this individual will support the strategic direction of GPS Operations, conduct a thorough analysis of current capabilities, and manage the development and implementation of operational improvements. The role will also provide mentorship to a capable team currently supporting clinical trial teams and vendor oversight to ensure the efficiency, quality, and compliance of the pharmacovigilance system, along with expanded responsibilities. Success in this role requires the ability to execute while building, work effectively in a dynamic and highly collaborative environment, and remain flexible and adaptive as priorities evolve.

• In collaboration with senior leadership, develop and implement strategic plans to ensure operational excellence, supporting the increasing demand for high-quality safety data collection, transformation, and reporting within a regulated environment (the pharmacovigilance system).
• Communicate complex pharmacovigilance and operational issues clearly, providing solutions that balance compliance with the demands of scale.
• Advance cross-functional initiatives that enhance the departments strategic impact and operational effectiveness and provide value to the overall positioning of the department.
• Translate business needs into scalable, well-documented pharmacovigilance systems and process configurations.
• Drive the development, optimization, and implementation of procedures, training, and documentation to support compliant and efficient pharmacovigilance operations.
• In collaboration with senior GPS leadership, manage the GPS Operations team ensuring case processing activities from all sources follow global regulations and internal requirements, create and analyze oversight metrics reports, review, approve, and trend late case investigations, ensure proper training is received and documented, and ensure the global safety database configuration is appropriate to meet company needs.
• Manage the resourcing, budget, and oversight of pharmacovigilance contract research organizations (PV CROs) regarding GPS Operations activities.
• In collaboration with safety science and other development staff, REMS (Risk Evaluation and Mitigation Strategies), RMP (Risk Management Plan) analyses, and ad hoc safety analysis as required by health authorities or corporate policy.
• Create and maintain the Pharmacovigilance System Master File (PSMF) to support European filings and regulations as applicable.
• Work with the EU Qualified Person Responsible for Pharmacovigilance (QPPV) to ensure European compliance as applicable.
• Author, review, and approve pharmacovigilance agreements (PVAs), and safety data exchange agreements (SDEA) with applicable partners.
• Responsible for ensuring inspection readiness for global inspections by ensuring all processes and training reflect global regulatory requirements.
• Influences and communications with executive management regarding PV strategy.

Required Skills, Experience and Education:

• Bachelors degree required. Advanced degrees in pharmacy, medicine, nursing, life sciences, or a related field .
• Experience (10+ years) in drug safety/pharmacovigilance within the pharmaceutical or biotechnology industry, with knowledge of safety operations, GCP, GVP, clinical trial conduct, data interpretation, process management, quality management, data interpretation, and safetys role in clinical development.
• A history of progressive leadership responsibilities.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH).
• Strong leadership and management skills, with a track record of building and developing high-performing teams.
• Excellent written and verbal communication, interpersonal, and influencing skills, with the ability to effectively collaborate with internal and external stakeholders.
• Proven ability to think strategically, drive innovation, and implement process improvements in drug safety operations.
• Experience interacting with regulatory agencies and participating in regulatory inspections and audits is required.
• Expert knowledge of US, EU, and global regulations governing pharmacovigilance.
• Expert knowledge of industry standard safety databases.
• Strong program management skills enabling efficient planning and execution of program milestones within budget and timelines.
• Strong vendor management skills with experience managing high profile projects with CROs and internal staff.
• Ability to build relationships and influence across disciplines, functions, and levels.
• Strong learning and the desire to share expertise and learn from others.
• Commitment to patients and the science that drives the shared mission.

Skills:

• Advanced degrees in pharmacy, medicine, nursing, life sciences, or a related field .

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