Remote Patient Safety Operations Manager

Regulatory Jobs; United States; Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Manager, Patient Safety Operations (Pharmacovigilance Operations Manager) to join our team in a remote capacity in the United States. You will manage and mentor Patient Safety staff, oversee safety activities, and ensure timely delivery of project milestones in line with client expectations.

The role emphasizes process optimization, regulatory compliance with ICH and GVP, collaboration across functions, and driving automation initiatives to enhance efficiency and safety

Qualifications

• Experience in pharmacovigilance operations and clinical research methods.
• Proven line management experience with coaching and development skills.
• Strong client interaction and cross-functional collaboration abilities.
• Knowledge of automation and AI applications in pharmacovigilance.

Responsibilities

• Manage and develop Patient Safety staff, delegate work according to budgets and hours, and coordinate resource assignments with leaders.
• Guide day-to-day team performance, create development plans, provide coaching and training, conduct appraisals and address performance concerns.
• Ensure work meets SLAs and KPIs for quality, compliance, and training.
• Provide functional expertise for Patient Safety processes, respond to team queries, and support urgent workload needs.
• Execute activities aligned with objectives, implement resource plans, and contribute to process improvement.
• Maintain knowledge of regulations and SOPs, support audits and quality investigations.
• Manage budgets and resources, forecast needs, track metrics, and escalate scope changes.
• Maintain client interactions, participate in meetings, and provide project updates to Senior Management.
• Collaborate with cross-functional teams and drive pharmacovigilance automation tool adoption.

Skills

Pharmacovigilance

People management

Client communication

Automation in PV

Clinical research methods

Education

Degree in Pharmacy

Nursing degree

Life Sciences degree

Equivalent experience

Job description

Parexel is seeking a Manager, Patient Safety Operations (Pharmacovigilance Operations Manager) to join our team in a remote capacity in the United States. You will manage and mentor Patient Safety staff, oversee safety activities, and ensure timely delivery of project milestones in line with client expectations.

The role emphasizes process optimization, regulatory compliance with ICH and GVP, collaboration across functions, and driving automation initiatives to enhance efficiency and safety