Manager, Patient Safety

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and manage Patient Safety personnel involved in designated projects.

• Direct daily operations, ensuring performance quality, adherence to timelines, and appropriate training.

• Allocate work based on budgetary constraints and available hours, while coordinating resource assignments.

• Develop training plans, offer coaching and mentoring, conduct performance evaluations, and address any performance issues.

• Ensure that all work adheres to Service Level Agreements and Key Performance Indicators.

• Provide functional expertise and oversight for Patient Safety procedures.

• Carry out Patient Safety tasks and contribute to initiatives aimed at process enhancement.

• Stay updated on regulations and Standard Operating Procedures.

• Assist in audits, inspections, quality investigations, risk management, and response actions.

• Oversee project budgets and resource distribution, forecast resource requirements, and monitor performance metrics.

• Manage client expectations, respond to feedback and concerns, and keep Senior Management informed about project status.

• Coordinate team efforts, review and confirm timesheets, and work collaboratively with cross-functional teams.

• Engage in the implementation and optimization of pharmacovigilance automation tools and digital solutions.

• Evaluate emerging technologies and suggest enhancements to safety workflows.

• Provide technical insights for business development efforts and assist in preparing materials and presentations.

⛳️ Requirements

• Bachelor’s degree in Pharmacy, Nursing, Life Sciences, another health-related field, or an equivalent qualification or relevant experience.

• Experience in managing teams effectively.

• Significant experience in client relations.

• Proficient knowledge of pharmacovigilance operations and clinical research methodologies.

• Strong understanding of clinical, regulatory, and medical Safety Services.

• Knowledge of ICH, CIOMS, GVP, and fundamental pharmacovigilance standards.

• Strong communication and collaboration skills.

• Familiarity with pharmacovigilance process enhancements, automation tools, and digital solutions is preferred.

• Understanding of audit and inspection requirements in pharmacovigilance is preferred.

• Knowledge of principles related to project budget management, resource allocation, and forecasting is preferred.

• Awareness of automation and artificial intelligence applications within pharmacovigilance.

• Candidates in other U.S. time zones must be flexible to provide coverage during EST hours.

🏝️ Benefits

• Health, Vision & Dental Insurance.

• Tuition Reimbursement.

• Vacation/Holiday/Sick Time.

• Flexible Spending & Health Savings Accounts.

• Work/Life Balance.

• 401(k) with Company match.

• Pet Insurance.

• Paid time off.

• Life insurance.