Rockefeller Philanthropy Advisors is seeking a Senior Specialist, Pharmacovigilance Quality and Compliance. This role is ideal for an experienced professional ready to advance quality and compliance standards within our highly regulated environment. You'll play a pivotal role supporting inspection readiness and ensuring regulatory compliance across global pharmacovigilance systems.
What You'll Do
- Support inspection and audit readiness by coordinating materials, logistics, and documentation for internal and external reviews.
- Investigate PV quality issues, perform root cause analysis, and monitor CAPA implementation.
- Maintain and update PV quality system documents, including SOPs, work instructions, and training records.
- Contribute to the development and maintenance of the Pharmacovigilance System Master File (PSMF).
- Manage PV agreements and track compliance with contractual obligations.
- Assist in training coordination, compliance monitoring, and maintenance of safety communication channels.
- Support vendor oversight, EU QPPV operations, and ensure accurate document control.
- Participate in cross-functional initiatives and strategic PV compliance projects.
What We're Looking For
- Bachelor’s degree in nursing, pharmacy, or a healthcare/life sciences-related field.
- Minimum 3+ years of experience in PV operations or quality roles within biotech, pharma, or healthcare.
- Strong knowledge of U.S. and international PV regulations (e.g., EU GVP, ICH, FDA).
- Experience with inspection and audit readiness, including addressing findings and implementing CAPAs.
- Hands-on experience with safety databases (e.g., Argus) and working with PV vendors.
- Excellent communication skills and the ability to collaborate across global, matrixed teams.
Nice to Have
- Experience in PV training, SOP development, vendor oversight, and safety system migrations.
Technical Stack
- Argus
Benefits & Compensation
- Competitive base salary ranging from $112,000 to $154,000, based on experience and location.
- Annual performance bonus and long-term incentive opportunities.
- Comprehensive medical, dental, and vision insurance coverage.
- 401(k) retirement plan with company match.
- Generous parental leave and family planning benefits.
- Opportunities for ongoing professional development in a collaborative and mission-driven environment.
Work Mode
This is a hybrid role based in Massachusetts.
Rockefeller Philanthropy Advisors is an equal opportunity employer.
