Title: Director, GSPV Operations, Process, Quality, and Compliance

Reports to: Vice President, Global Safety and Pharmacovigilance

Location: Remote Position

Position Overview

The Director Global Safety and Pharmacovigilance (GSPV) Operations, Process, Quality and Compliance is responsible for the establishment, maintenance and oversight of appropriate procedures, metrics, and systems to assure compliance to global regulatory requirements for the collection, processing, and reporting of safety information throughout the product life cycle, (pre- through post-marketing). The incumbent serves as a strategic partner in managing GSPV quality and will provide support and collaboration internally and externally to ensure all systems, processes and outcomes comply with applicable global regulations and guidances, and industry and Company standards. This role will be deployed across the key areas of process and performance within the GSPV Operations remit: safety report case management, quality & compliance, safety agreements, and vendor management.

Responsibilities

• Develop GSPV strategy and infrastructure for GSPV processes, quality, and compliance; lead departmental process improvement

• Develop, implement, maintain, and revise GSPV documents, including but not limited to: GSPV SOPs/WIs, PSMF, SDEA's, other GSPV related documents and policies

• Develop and monitor quality control parameters for GSPV processes and assume responsibility for ensuring internal reviews and quality checks are performed and documented

• Develop, monitor, and assess compliance metrics to ensure compliance goals are met

• Establish and maintain Pharmacovigilance inspection readiness in collaboration with GSPV subject matter experts (SMEs) and Clinical Quality Assurance; function as company's representative during regulatory agency inspections and vendor audits; author responses to audit/inspection findings relevant to functional area

• Support strategic direction with cross functional working groups to identify and mitigate GSPV quality and compliance gaps/issues/risks

Function as operational lead for case management, including but not limited to vendor oversight, forecasting, budgeting, compliance, key performance indicators, and training, as applicable

• Author and maintain various pharmacovigilance documents, including but not limited to safety management plans, safety data exchange agreements, safety handling plans, or business partner contracts or agreements and memorandum, as applicable.

• Oversee and monitor activities of vendors/CROs/business partners to ensure adherence and compliance with applicable study protocols, Safety Management Plans, SOPs and WIs, defined metrics, and contractual agreements

• Lead GSPV training curricula development and maintenance in conjunction with Clinical Quality Assurance

• Develop, review, maintain, and revise relevant GSPV document templates (e.g., SAE report forms, safety data entry guidelines, DSURs, etc.).

• Monitor industry best practices, changes in global safety regulations and guidances and, based on changes, develop and/or modify to departmental plans, policies, and procedures, as needed

• Supervise and provide oversight of operations personnel (direct reports, consultants, and vendors) including mentoring, training, and monitoring compliance, as applicable

• Other duties as assigned

Requirements

Education and/or Experience:

• Master's degree in relevant field (Life sciences), nursing degree or pharmacy degree required; for exceptional candidates, a Bachelor of Science Degree in Life Sciences (nursing or pharmacy) combined with relevant experience will be considered

• A minimum of 8-10 years of experience in pharmacovigilance with a focus on operations, across clinical trial and post-marketed phases, is required

• Role requires successful proven-track record of 2-4 years' experience in a similar role

• Experience with effectively managing regulatory agency inspections and working with regulators and internal staff to help prepare for inspections; experience with preparation of responses to audits/inspections, including corrective and preventative actions

• Strong knowledge and understanding of drug, device, and vaccine FDA, EU and ICH regulations, pharmacovigilance regulations/processes and HA inspection procedures is required

• Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices and ICH E-6 for Good Clinical Practice

• Demonstrate ability to provide critical and timely insight, and analytical critical thinking skills with a broad perspective

• Proven experience with currently available drug safety database systems (Argus preferred), document management systems and QC tools, including MedDRA and WHODrug coding experience

Competencies and Attributes:

• Requires demonstrated leadership to drive results that are needed to achieve company objectives in accord with Company's culture and values - courageous, imaginative, selfless, and joyful

• The position demands excellent people skills, independent decision-making, and flexibility to adapt to a fast-paced, dynamic, and complex regulatory and business environment

• Strong collaborator who is solution oriented and has a customer service approach

• Ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop and drive realistic plans, programs, and recommendations

• Strong attention to detail and the ability to work independently, as well as within a multi-disciplinary team and with external partners and vendors

• This position requires a commitment to process improvements, excellent organizational skills, excellent written and verbal communication skills, a strong commitment to best practices, and the ability to work effectively as both a functional area manager as well as cross-functional project team member

• Demonstrated ability; excellent analytical skills, an ability to communicate complex issues in a straightforward way and to orchestrate plans to resolve issues and mitigate risks

• Computer literacy is essential