Senior Patient Safety Training Manager

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Spearhead and manage the comprehensive Patient Safety training strategy for both onboarding and on-the-job training within pharmacovigilance and Safety functions.

• Supervise the governance of training for internal and external vendors, including the development, implementation, maintenance, qualification, and performance monitoring.

• Facilitate strategic discussions and make informed decisions alongside Patient Safety leadership and cross-functional stakeholders.

• Create and uphold vendor training procedures, governance standard operating procedures (SOPs), training standards, and acceptance/qualification criteria.

• Hold primary responsibility for addressing training-related deviations and corrective actions impacting vendor training processes.

• Assist in preparing for inspections and serve as a member of the inspection team.

• Retrain Patient Safety personnel and provide constructive feedback on training goals and performance.

• Establish quality checkpoints to monitor and assess the training and development of Patient Safety staff.

• Design and conduct both internal and external safety training.

• Identify areas for training improvement and implement solutions for safety personnel and suppliers.

• Support the development of Patient Safety eLearning modules within the Learning Management System.

• Lead initiatives for continuous improvement.

• Convert regulatory and SOP requirements into effective training materials, guidance, and operational best practices.

• Maintain controlled, versioned, and audit-ready training governance documentation and records.

• Analyze training-related deviations and corrective action plans (CAPAs) and facilitate prompt resolution of corrective actions.

• Implement automated solutions to enhance operational efficiency, metric tracking, and KPI management.

• Identify and assess technologies to optimize vendor oversight, onboarding, learning, project tracking, mailbox management, and reporting.

⛳️ Requirements

• A Bachelor's Degree in Nursing, Pharmacy, or a related medical or scientific field is required; relevant experience can be considered in lieu of a degree.

• Preferred experience in Pharmacovigilance training or mentorship.

• Familiarity with medical terminology.

• Exceptional presentation, interpersonal, stakeholder management, and coaching abilities.

• Proven ability to influence cross-functional stakeholders and lead training initiatives effectively.

• Knowledge of GxP compliance training and oversight reporting.

• High proficiency in Microsoft PowerPoint, Word, Outlook, and Excel.

• Understanding of automation and artificial intelligence tools.

• Creative and proficient in content creation.

• Strong project management capabilities with the ability to juggle multiple projects.

• Knowledge of safety database systems, reporting tools, SOPs, NNI-GS Agreements, FDA safety reporting guidelines, and Good Clinical Practice (GCP).

• Current knowledge of regulations and guidelines from the FDA, Health Canada, and ICH.

• Willingness to travel approximately 10% overnight.

🏝️ Benefits

• Company bonus based on individual and company performance.

• Long-term incentive compensation and/or company vehicles based on position level or company factors.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Life insurance.

• Disability insurance.

• 401(k) savings plan.

• Flexible spending accounts.

• Employee assistance program.

• Tuition reimbursement program.

• Group legal benefits.

• Critical illness benefits.

• Identity theft protection.

• Pet insurance.

• Auto/home insurance.

• Sick time policy.

• Flexible vacation policy.

• Parental leave policy.