Senior Pharmacovigilance Project Lead

Parexel; Nashville (TN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Tuition reimbursement

Vacation time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet insurance

Job summary

Parexel is seeking a Senior Patient Safety Project Lead to join our pharmacovigilance team in Nashville. You will lead strategic client relationships, oversee global safety projects, and ensure regulatory compliance and high-quality safety outputs.

In this role, you will manage project plans, budgets, forecasting, and cross-functional collaboration across Medical, Operations, Data Management, and Health Authorities.

Qualifications

• Degree in Pharmacy, Nursing, Life Science, or other health related field, or relevant work experience in Pharmacovigilance
• Minimum 7+ years of experience in drug development and/or healthcare environments
• Experience with managing safety stand-alone projects
• Extensive drug safety and pharmacovigilance experience with demonstrated project management and team leadership capabilities
• Strong knowledge of ICH, GCP, regulatory requirements, and pharmacovigilance processes
• Experience working with pharmacovigilance systems, safety databases, and project lifecycle management processes
• Strong communication, organization, financial management, and decision making skills
• Strong command of written and spoken English

Responsibilities

• Establish and maintain collaborative client relationships that drive trust, operational excellence, and successful project delivery
• Lead patient safety programs and partnerships by developing project plans, managing milestones, monitoring performance, and ensuring timely delivery of agreed outcomes
• Provide strategic oversight of project financials, including budgeting, forecasting, resource planning, revenue recognition, invoicing, and scope change management
• Serve as a key client contact, proactively addressing challenges, communicating project status, and coordinating solutions with internal stakeholders
• Contribute subject matter expertise to proposals, business development activities, bid defenses, and governance meetings
• Collaborate with cross functional teams, including Business Operations, Clinical Operations, Data Management, and other functional areas to achieve program objectives
• Partner with clients, vendors, health authorities, and internal subject matter experts to support high quality service delivery
• Ensure all deliverables meet quality standards and comply with ICH, GCP, FDA, EMA, and other applicable regulatory requirements
• Apply advanced knowledge of pharmacovigilance systems, safety processes, and regulatory expectations to support operational excellence
• Stay current with industry trends, emerging regulations, and best practices to continuously improve patient safety operations
• Represent Patient Safety during audits and support the implementation of corrective and preventive actions when required
• Provide leadership, mentorship, and functional oversight across teams, including support during management absences

Skills

Project leadership

Client relationship mgmt

Financial oversight

Pharmacovigilance experience

Regulatory knowledge

Cross-functional collaboration

English communication

Education

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

Tools

Pharmacovigilance systems

Safety databases

Job description

Parexel is seeking a Senior Patient Safety Project Lead to join our pharmacovigilance team in Nashville. You will lead strategic client relationships, oversee global safety projects, and ensure regulatory compliance and high-quality safety outputs.

In this role, you will manage project plans, budgets, forecasting, and cross-functional collaboration across Medical, Operations, Data Management, and Health Authorities.