[Hiring] Manager, Patient Safety @Parexel

Role Description

We are seeking a Manager, Patient Safety Operations (Pharmacovigilance Operations Manager, Drug Safety Operations Manager) to join our team in a remote capacity.

As a Manager, Patient Safety Operations, you will:

• Manage and supervise Patient Safety staff supporting assigned projects.
• Guide day-to-day performance, quality, timeline compliance, and training.
• Provide process expertise across project-specific safety activities.
• Communicate directly with clients to address questions, feedback, and escalations.
• Join a collaborative environment to strengthen team capabilities and improve pharmacovigilance operations.

Key Responsibilities

• Manage and develop Patient Safety staff, delegate work according to allocated budgets and hours.
• Guide day-to-day team performance, create development plans, provide coaching and training.
• Ensure assigned work meets Service Level Agreements and defined Key Performance Indicators.
• Provide functional expertise and oversight for Patient Safety processes.
• Execute Patient Safety activities aligned with team objectives and contribute to process improvement initiatives.
• Maintain current knowledge of relevant regulations and support audits, inspections, and quality investigations.
• Manage project budgets and resource allocation, track performance metrics, and manage client expectations.
• Maintain professional client interactions and provide periodic project updates to Senior Management.
• Coordinate team activities and support team cohesion.
• Participate in the implementation and optimization of pharmacovigilance automation tools.
• Provide technical input for business development activities and support the preparation of materials and presentations.

Qualifications

• Excellent clinical, regulatory, and medical Safety Services knowledge.
• Working knowledge of pharmacovigilance operations and clinical research methodologies.
• Line Management experience and the ability to coach and develop staff.
• Experience interacting professionally with clients and working collaboratively across functions.
• Awareness of automation and artificial intelligence applications in pharmacovigilance.
• An adaptable mindset with enthusiasm for learning and teamwork.

Requirements

• Degree in Pharmacy, Nursing, Life Science, or another health-related field, or equivalent qualification or relevant work experience.
• People management experience.
• Considerable experience working with clients.
• Understanding of ICH, CIOMS, GVP, and basic pharmacovigilance requirements.
• Effective communication and teamwork skills.

Preferred Qualifications

• Familiarity with pharmacovigilance process improvements, automation tools, and digital solutions.
• Knowledge of pharmacovigilance audit and inspection requirements.
• Understanding of project budget management and resource allocation principles.

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.