Senior Patient Safety and Pharmacovigilance Operations Specialist II

The Manager, Patient Safety & Pharmacovigilance (PSPV) Compliance, Standards, and Training is responsible for supporting and managing activities for the execution and day-to-day oversight of PSPV compliance activities, including metrics/KPIs, maintenance of procedures, training programs, and quality system processes supporting both investigational and marketed products. This role partners closely with PSPV sub-functions, Quality Assurance, Clinical, Regulatory, and external vendors to ensure ongoing regulatory compliance.

Key Responsibilities

• Support operation and maintenance of the PSPV Quality Management System (QMS), ensuring procedures and processes are implemented consistently and in alignment with regulatory requirements
• Author, review, revise, and maintain PSPV procedures, work instructions, and related controlled documents in compliance with global PV regulations (FDA, EMA, ICH)
• Contribute to and manage activities for the development, implementation, and maintenance of role-based PV training programs, including initial and refresher training as well as monitoring of training completion and related compliance metrics/key performance indicators (KPIs)
• Contribute to and manage activities for the development, compilation and reporting of PV compliance metrics and KPI activities, including assessment of performance trends, compliance status, and identification of potential areas for improvement
• Support PSPV inspection readiness activities, including preparation of documentation, participation in mock inspections, and support of regulatory inspections
• Manage deviation, CAPA, and change control activities related to PSPV processes, including investigation support, documentation, and effectiveness checks
• Monitor changes in pharmacovigilance regulations and guidelines and support implementation of required procedural or training updates
• Support activities for the review, update, and ongoing maintenance of the Pharmacovigilance System Master File (PSMF), including coordination of routine reviews and contribution updates across functions and vendors

Required Skills and Qualifications

• Ability to operate effectively in a regulated, fast-paced environment while managing multiple priorities
• Strong working knowledge of pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH requirements
• Experience with Quality Management Systems (e.g., Veeva or similar systems) are a plus
• Strong organizational, documentation, and attention-to-detail skills
• Effective written and verbal communication skills with the ability to collaborate across functions and with external vendors

Education and Experience

• Bachelor's degree in life sciences, healthcare, or a related discipline; advanced degree (e.g., RN, BSN, PharmD) preferred
• Minimum of 5 years of experience in Patient Safety/PV with 2+ years of related experience in PV compliance, standards, training, or quality system activities
• Experienced in managing quality events (deviations, CAPAs, change controls)
• Inspection/audit support experience and project management skills preferred

The pay range that the Company reasonably expects to pay for this headquarters-based position is $160,000 – $200,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.