Full-Time Senior Specialist Pharmacovigilance

Senior Specialist, Pharmacovigilance (PV) Quality and Compliance encompasses a key role in providing direction to the PV department and promotes 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 reports to the Senior Manager, Pharmacovigilance (PV) Quality and Compliance and is remote or near the Waltham, MA office.

1. Support the preparation and readiness of the pharmacovigilance (PV) system for internal audits and external regulatory inspections.
2. Assist in conducting investigations into PV quality issues and ensure proper documentation of root cause analyses and CAPA implementation.
3. Collaborate with QA and PV teams to support audit/inspection activities, including coordination of inspection readiness materials and logistics.
4. Maintain key PV quality system documentation, such as SOPs, work instructions (WIs), and training records, ensuring updates are performed in a timely manner.
5. Contribute to the creation and review of the Pharmacovigilance System Master File (PSMF) and associated documentation to ensure compliance with global regulatory requirements.
6. Coordinate the review and management of PV agreements (PVAs) and track team compliance with obligations outlined in the agreements.
7. Support the execution of PV training activities, including maintenance of training records, training matrices, and compliance tracking for mandatory PV training.
8. Collaborate with internal stakeholders to support effective document control, record retention, and access to PV-related quality documents.
9. Assist in managing vendor and business partner oversight by supporting audit follow-ups, tracking CAPA implementation, and ensuring appropriate documentation.
10. Provide operational support to the EU QPPV office and contribute to the maintenance of quality-related deliverables.
11. Help monitor and maintain safety operations communication channels (e.g., distribution lists and mailboxes) to ensure timely response and triage.
12. Contributes to strategic initiatives across PV, as required.

What You’ll Bring:

• Bachelor’s degree in nursing, pharmacy, or a healthcare/life sciences-related field.
• Minimum of 3+ years of experience in Pharmacovigilance (PV) operations and/or quality roles within the pharmaceutical, biotech, or healthcare industry.
• Experience supporting or participating in regulatory inspection and audit readiness activities, including involvement in addressing audit and inspection findings.
• Working knowledge of U.S. and global PV regulations, guidelines and compliance (e.g., U.S. CFR, EU GVP, ICH).
• Experience working with contract service providers in PV functions such as case processing, aggregate reporting, and quality management.
• Familiarity with regulatory inspections and audits, including MHRA and/or EMA PV inspections.
• Hands-on experience with safety databases (e.g., Argus) for case management and regulatory reporting.
• Strong interpersonal and communication skills, with the ability to work independently and collaboratively in cross-functional teams.

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