Senior Specialist, Pharmacovigilance Quality and Compliance - Remote

Overview

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.

In Short

• 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.

Requirements

• Experience in pharmacovigilance and quality compliance.
• Strong understanding of regulatory requirements and quality standards.
• Excellent analytical and problem-solving skills.
• Ability to manage multiple projects and priorities.
• Strong communication and collaboration skills.

Benefits

• Flexible work arrangements (hybrid or fully remote).
• Engagement in high-impact initiatives.
• Opportunity for professional growth and development.