Remote Pharmacovigilance Operations Manager

Parexel; Hartford (CT); Remote; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health 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 to lead and develop Patient Safety staff, ensuring quality, timeliness, and regulatory compliance across projects in a remote US capacity.

You will provide expertise in ICSR processing, signal and risk management, safety writing, and PV automation tools, while coordinating with clients and cross-functional teams to deliver high-quality safety services for clinical research.

Qualifications

• Degree in Pharmacy, Nursing, Life Science, or related field.
• People management experience.
• Experience working with clients.
• Knowledge of pharmacovigilance operations and clinical research methodologies.
• Understanding of ICH, CIOMS, GVP, and basic pharmacovigilance requirements.
• Strong communication and teamwork skills.

Responsibilities

• Lead and develop Patient Safety staff and manage budgets and hours.
• Ensure quality, compliance, and timely delivery of safety activities.
• Provide process expertise across PV activities including ICSR processing and risk management.
• Communicate with clients to address questions and escalations.
• Support automation tools and digital solutions in PV workflows.
• Coordinate with cross-functional teams and senior management.

Skills

Clinical safety knowledge

Pharmacovigilance operations

Line management

Client communication

Process improvement

Automation awareness

Education

Bachelor's in Pharmacy or Life Sciences

Job description

Parexel is seeking a Manager, Patient Safety Operations to lead and develop Patient Safety staff, ensuring quality, timeliness, and regulatory compliance across projects in a remote US capacity.

You will provide expertise in ICSR processing, signal and risk management, safety writing, and PV automation tools, while coordinating with clients and cross-functional teams to deliver high-quality safety services for clinical research.