Remote Patient Safety Ops Manager (Pharmacovigilance)

Parexel; Honolulu (HI); Remote; USD 150,000 - 190,000; 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 lead a remote-capacity team. You will supervise staff, ensure quality, timelines, and compliance across PV activities, and collaborate with clients and cross-functional teams.

The role emphasizes process improvement, audits, and adoption of automation tools to enhance efficiency and safety outcomes in clinical research. Strong leadership and regulatory expertise are essential.

Qualifications

• Degree in Pharmacy, Nursing, Life Science, or related field or equivalent experience.
• People management experience.
• Experience working with clients.
• Working knowledge of pharmacovigilance operations and clinical research methodologies.
• Understanding of ICH, CIOMS, GVP, and basic pharmacovigilance requirements.
• Excellent clinical, regulatory, and medical Safety Services knowledge.
• Effective communication and teamwork skills.

Responsibilities

• Manage and develop Patient Safety staff, delegate work according to budgets and hours, coordinate resource needs with leaders.
• Guide day-to-day team performance, create development plans, provide coaching and training, conduct appraisals, address performance concerns.
• Ensure work meets SLAs and KPIs for quality, compliance, and training.
• Provide functional expertise and oversight for Patient Safety processes, respond to team queries, support urgent workload when needed.
• Execute Patient Safety activities aligned with team objectives, implement resource utilization plans, contribute to process improvement initiatives.
• Maintain knowledge of relevant regulations and Parexel SOPs, support audits, inspections, quality investigations, risk mitigation, and response activities.
• Manage project budgets and resource allocation, forecast needs, track metrics, manage client expectations, identify scope changes for escalation.
• Maintain client interactions, participate in meetings, address feedback and provide periodic project updates to Senior Management.
• Coordinate team activities, review timesheets, communicate decisions and policies, support team cohesion, collaborate with cross-functional teams.
• Participate in PV automation tools implementation and analyze performance.
• Assess emerging technologies, recommend improvements to safety workflows, contribute to innovation roadmaps.
• Provide technical input for business development and support materials/presentations.

Skills

People management

Client interaction

Automation in PV

PV operations knowledge

Communication

Education

Degree in Pharmacy, Nursing, Life Science, or related field

Job description

Parexel is seeking a Manager, Patient Safety Operations (Pharmacovigilance Operations Manager) to lead a remote-capacity team. You will supervise staff, ensure quality, timelines, and compliance across PV activities, and collaborate with clients and cross-functional teams.

The role emphasizes process improvement, audits, and adoption of automation tools to enhance efficiency and safety outcomes in clinical research. Strong leadership and regulatory expertise are essential.