Senior Patient Safety Project Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and sustain collaborative relationships with clients.

• Lead initiatives in patient safety programs and partnerships by creating project plans, managing key milestones, monitoring performance, and ensuring timely execution.

• Supervise budgeting, forecasting, resource allocation, revenue recognition, invoicing, and management of scope changes.

• Act as the primary contact for clients, addressing challenges, communicating project status, and coordinating solutions.

• Provide subject matter expertise for proposals, business development efforts, bid defenses, and governance meetings.

• Work in collaboration with Business Operations, Clinical Operations, Data Management, and other cross-functional teams.

• Collaborate with clients, vendors, health authorities, and internal experts.

• Ensure that deliverables meet quality benchmarks and comply with ICH, GCP, FDA, EMA, and other regulatory standards.

• Utilize advanced knowledge of pharmacovigilance systems, safety processes, and regulatory expectations.

• Keep abreast of industry trends, emerging regulations, and best practices.

• Represent Patient Safety during audits and assist in corrective and preventive actions.

• Provide leadership, mentorship, and functional oversight across teams.

⛳️ Requirements

• Bachelor’s degree in Pharmacy, Nursing, Life Science, or a related health field, or equivalent work experience in Pharmacovigilance.

• At least 7+ years of experience in drug development and/or healthcare settings.

• Proven experience in managing stand-alone safety projects.

• Extensive experience in drug safety and pharmacovigilance with demonstrated project management and team leadership skills.

• In-depth knowledge of ICH, GCP, regulatory requirements, and pharmacovigilance processes.

• Familiarity with pharmacovigilance systems, safety databases, and project lifecycle management processes.

• Strong skills in communication, organization, financial management, and decision-making.

• Proficient in written and spoken English.

🏝️ 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.

• Paid time off.

• Life insurance.

• Additional benefits in accordance with applicable plans.