Senior Patient Safety Project Lead

Parexel; Columbia (SC); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Senior Patient Safety Project Lead to oversee pharmacovigilance services in a fast-paced environment. This role demands strong project leadership, client management, and regulatory compliance skills as you manage safety-related projects and build collaborative client relationships.

Join a dynamic team committed to advancing patient safety and driving operational excellence across complex global programs.

Qualifications

• Minimum 7+ years of experience in drug development and/or healthcare environments.
• Experience managing safety stand-alone projects.
• Strong knowledge of ICH, GCP, and regulatory requirements.

Responsibilities

• Lead patient safety programs and partnerships.
• Provide strategic oversight of project financials.
• Ensure compliance with regulatory requirements.

Skills

Project leadership

Client relationship management

Financial oversight

Pharmacovigilance experience

Communication skills

Problem solving

Education

Degree in Pharmacy, Nursing, Life Science

Tools

Pharmacovigilance systems

Safety databases

Job description

About Parexel

Parexel is a leading global clinical development partner delivering insights driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the Role

We are seeking a Senior Patient Safety Project Lead (Pharmacovigilance Project Lead, Drug Safety Project Lead) to join our team.

As a Senior Patient Safety Project Lead, you will play a critical role in delivering patient safety services across complex global programs and partnerships. This position is responsible for leading strategic client relationships, overseeing operational delivery, driving project performance, and ensuring the highest standards of pharmacovigilance quality and regulatory compliance.

You will serve as a trusted partner to clients and internal stakeholders, providing expertise across project planning, financial oversight, process optimization, and patient safety operations. Responsibilities include managing project scope, timelines, budgets, forecasting, quality outcomes, and cross functional collaboration, with opportunities to influence innovative solutions that support the development of life changing therapies. This role will focus primarily on supporting safety stand-alone projects.

You’ll join a fast paced, growth oriented environment focused on advancing patient safety, strengthening client partnerships, and driving operational excellence. With diverse teams and continuous learning opportunities, the Senior Patient Safety Project Lead can expand expertise across pharmacovigilance, project leadership, and strategic partnership management while helping shape the future of clinical research.

Key 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

Candidate Profile

You’ll thrive in this role if you bring:

• Strengths in project leadership, client relationship management, and financial oversight
• Experience working in pharmacovigilance, drug development, healthcare, or other regulated environments
• The ability to build collaborative partnerships across cross functional and matrixed teams
• A patient focused mindset with a commitment to quality, compliance, and continuous improvement
• Comfort working with pharmacovigilance systems, safety databases, project management processes, and governance frameworks
• Excellent communication, prioritization, and problem solving skills with the ability to manage multiple complex initiatives simultaneously

Required 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

Preferred Qualifications

• Certification in project management
• Experience supporting clinical adjudication committees and data monitoring committees
• Familiarity with IDRA workflows, committee governance processes, and adjudication technology platforms
• Comprehensive understanding of global pharmacovigilance systems and regulatory requirements

Benefits and Compensation

• 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

For a complete list of benefits, please visit www.parexel.com/us-benefits .

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.