Senior Pharmacovigilance Program Lead

Parexel; Providence (RI); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health insurance

401(k) match

Tuition reimbursement

Paid time off

HSA/FSAs

Pet insurance

Work/Life balance

Job summary

Parexel is seeking a Senior Patient Safety Project Lead to join our team. You will lead pharmacovigilance projects globally, manage client relationships, and oversee operational delivery across complex programs.

You will drive project performance, financial oversight, and ensure regulatory compliance, while collaborating with cross-functional teams to deliver high-quality patient safety services.

Qualifications

• Degree in Pharmacy, Nursing, Life Science, or related field, or PV experience.
• 7+ years of experience in drug development or healthcare environments.
• Experience managing safety stand-alone projects.
• Extensive drug safety and pharmacovigilance with leadership.
• Strong knowledge of ICH, GCP, regulatory requirements.
• Experience working with PV systems and safety databases.
• Strong communication, organization, financial management, and decision making.
• Excellent written and spoken English.

Responsibilities

• Establish and maintain collaborative client relationships that drive trust, operational excellence, and successful project delivery
• Lead patient safety programs by developing project plans, managing milestones, monitoring performance, and ensuring timely delivery of 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, addressing challenges, communicating 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 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 regulatory requirements
• Apply advanced knowledge of pharmacovigilance systems and safety processes
• Stay current with industry trends and regulations to improve operations
• Represent Patient Safety during audits and support CAPA efforts
• Provide leadership and mentorship across teams

Skills

Project leadership

Client relationship management

Financial oversight

Pharmacovigilance experience

Communication

English proficiency

Cross-functional collaboration

Education

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

Tools

Pharmacovigilance systems

Safety databases

Project lifecycle management

Job description

Parexel is seeking a Senior Patient Safety Project Lead to join our team. You will lead pharmacovigilance projects globally, manage client relationships, and oversee operational delivery across complex programs.

You will drive project performance, financial oversight, and ensure regulatory compliance, while collaborating with cross-functional teams to deliver high-quality patient safety services.