
Senior Specialist, Pharmacovigilance Quality and Compliance at Jobgether. This position is posted by Jobgether on behalf of Deciphera Pharmaceuticals. We are currently looking for a Senior Specialist, Pharmacovigilance Quality and Compliance in Massachusetts (USA).. This opportunity is ideal for an experienced pharmacovigilance professional looking to advance quality and compliance standards within a highly regulated environment. You'll play a pivotal role in supporting inspection readiness, managing quality documentation, and ensuring regulatory compliance across global PV systems. The position offers a hybrid or fully remote setup, allowing for flexibility while remaining engaged in high-impact initiatives across clinical and post-marketing safety operations.. Accountabilities:. . 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, WIs, 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.. . . 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.. . Preferred: experience in PV training, SOP development, vendor oversight, and safety system migrations.. . Company Location: United States.