The Senior Specialist, Pharmacovigilance (PV) Quality and Compliance encompasses a key leadership role in providing direction to the PV department and promote the spirit of proactive, continuous quality improvement in adverse event case management for all Deciphera Pharmaceuticals Clinical Trials, Extended Access Programs and post marketing (where applicable).This position will report to the Senior Manager, Pharmacovigilance (PV) Quality and Compliance and be remote or near the Waltham, MA office.Key Responsibilities:Support the preparation and readiness of the pharmacovigilance (PV) system for internal audits and external regulatory inspections.Assist in conducting investigations into PV quality issues and ensure proper documentation of root cause analyses and CAPA implementation.Collaborate with QA and PV teams to support audit/inspection activities, including coordination of inspection readiness materials and logistics.Maintain key PV quality system documentation, such as SOPs, work instructions (WIs), and training records, ensuring updates are performed in a timely manner.Contribute to the creation and review of the Pharmacovigilance System Master File (PSMF) and associated documentation to ensure compliance with global regulatory requirements.Coordinate the review and management of PV agreements (PVAs) and track team compliance with obligations outlined in the agreements.Support the execution of PV training activities, including maintenance of training records, training matrices, and compliance tracking for mandatory PV training.Collaborate with internal stakeholders to support effective document control, record retention, and access to PV-related quality documents.Assist in managing vendor and business partner oversight by supporting audit follow-ups, tracking CAPA implementation, and ensuring appropriate documentation.Provide operational support to the EU QPPV office and contribute to the maintenance of quality-related deliverables.Help monitor and maintain safety operations communication channels (e.g., distribution lists and mailboxes) to ensure timely response and triage.Contributes to strategic initiatives across PV, as required.
