Senior Patient Safety Data Acquisition and Support Manager
Function: Regulatory Affairs & Safety Pharmacovigilance
Location: Plainsboro, New Jersey, United States
Employment Type: Full-Time
Industry: Pharmaceuticals | Patient Safety | Pharmacovigilance | Healthcare Operations
Job Overview
We are seeking an experienced Senior Patient Safety Data Acquisition and Support Manager to lead and optimize patient safety data acquisition, contact center operations, and product safety compliance across patient support programs. This role plays a critical part in ensuring regulatory compliance, operational excellence, and a patient-centric experience through effective vendor oversight, safety monitoring, analytics, and cross-functional collaboration.
The position requires a seasoned professional with strong leadership, project management, and pharmacovigilance expertise who can operate independently while partnering across commercial, regulatory, medical, and safety teams.
About the Department
The Clinical, Medical and Regulatory (CMR) department is a highly collaborative and diverse function supporting medical education, regulatory strategy, product safety, and real-world data collection. With a strong patient-first philosophy, the department works closely with internal and external stakeholders to improve patient outcomes and ensure compliance with global regulatory standards.
Key Responsibilities
Patient Safety & Compliance
Serve as a subject matter expert in identifying, documenting, and reporting adverse events, product complaints, and safety information in compliance with FDA and internal pharmacovigilance requirements.
Ensure product safety compliance across all Patient Support Programs, including contact centers, reimbursement hubs, and affordability programs.
Represent the function during internal and external safety audits and inspections.
Contact Center & Vendor Management
Oversee daily operations of patient support contact centers, including phone, digital, and emerging communication channels.
Manage end-to-end vendor operations, including SOPs, workflows, scripting, training, reporting, and exception handling.
Lead and manage 100+ external vendor agents, ensuring training compliance and performance alignment with organizational standards.
Support live patient services for in-line and future product launches in coordination with hubs and reimbursement partners.
Data Analytics & Reporting
Communicate data and analytics requirements and translate insights into actionable performance improvements.
Collaborate on dashboards and KPI reporting to monitor trends, risks, and operational effectiveness.
Drive continuous improvement in analytics quality, reporting accuracy, and data-driven decision-making.
Program & Project Management
Coordinate cross-functional and department-wide projects, ensuring timelines, milestones, and deliverables are met.
Manage PRB processes for contact center programs and ensure sustainable project execution.
Identify process improvement opportunities to enhance efficiency, compliance, and patient experience.
Customer Experience & Business Support
Enhance patient support program experiences through benchmarking, audits, feedback analysis, and call monitoring.
Develop and implement best practices to address operational challenges and customer service gaps.
Maintain strong collaboration with Commercial, Medical, Regulatory, Quality, Legal, IT, Privacy, and Finance teams.
People Development & Leadership
Support the development of vendor teams through structured training programs and performance management.
Ensure alignment with organizational policies, procedures, and ethical standards.
Required Qualifications & Experience
Education
Bachelor’s degree in healthcare, life sciences, business, or a related discipline required.
MBA or advanced degree preferred.
Professional Experience
Minimum 5 years of experience in pharmaceutical operations, patient safety, market access, marketing, project management, or related healthcare roles.
Prior experience in pharmacovigilance, patient safety, or healthcare operations is strongly preferred.
Proven experience managing external vendors and cross-functional teams.
Hands-on experience with CRM systems, safety databases, and telephony platforms.
Key Skills & Competencies
Strong understanding of the pharmaceutical industry, including regulatory, legal, medical, and clinical processes.
Demonstrated expertise in adverse event reporting and patient safety compliance.
Excellent project management, analytical, and problem-solving skills.
Strong stakeholder management and vendor oversight capabilities.
Proficiency in Microsoft Word, Excel, PowerPoint, and Windows-based systems.
Excellent written, verbal, and interpersonal communication skills with a customer-focused mindset.
Travel Requirement
Up to 10% overnight travel.
Compensation & Benefits
Base Salary Range: USD 116,810 – 216,100 annually, based on experience, location, and internal equity.
Eligibility for annual performance-based bonus and comprehensive benefits package.
Equal Opportunity Statement
We are committed to fostering an inclusive and equitable recruitment process. All qualified applicants will receive consideration without regard to race, gender, age, disability, veteran status, or any legally protected characteristic.
Important Notice
Job titles may be updated as part of a global alignment process. All recruitment activities follow strict ethical standards, and no fees or payments are required at any stage of the hiring process.
About the Organization
Driven by a strong purpose to defeat serious chronic diseases, this organization combines scientific excellence with a patient-first mindset. Through innovation, collaboration, and integrity, it continues to advance healthcare solutions that create long-term value for patients worldwide.
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