Senior Manager, Pharmacovigilance Quality
Found in: Resume Library US A2 - 2 weeks ago
The Senior Manager, Pharmacovigilance (PV) Quality 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 Director, Pharmacovigilance Operations and be in the Waltham office.
Key Responsibilities:
Conducts gap analyses and prepares PV subject matter experts in preparation for regional PV audits and inspections of the PV system
Conducts investigations into quality issues identified within PV and ensures event analyses, root cause investigations, corrective, and preventive actions (CAPA) are thoroughly documented
Ensures PV support is provided to QA teams to facilitate the preparation and management of regional regulatory inspections (i.e. US, EU and other applicable countries); provides inspection readiness training and ongoing communication of the outcomes of such inspections to internal PV team
Develops PV storyboards for utilization during PV audits and inspections
Ensures the effective functioning of PV quality management system in compliance with global regulatory authority expectations
Supports the development and implementation of PV Key Performance Indicators (KPI's) used to determine the effectiveness of the overall pharmacovigilance system
Provides PV support to the conduct of audits and inspections of business partners and vendors conducting PV activities on behalf of Deciphera
Conducts follow-up of business partner and vendor CAPA plans implemented because of findings identified during PV audits and inspections
Supports the implementation of business continuity plans globally
Represents PV as a subject matter expert during audits and inspections
Responsible for the definition of standards and the timely management of PV policies, Standard Operating Procedures (SOP) and Working Instructions (WI)
Reviews and coordinates subject matter input into cross-functional policies, SOPs & WIs
Manages the authoring/review/approval and ongoing maintenance of the PV Quality Management Plan with vendors, as applicable
Executes the monitoring and impact assessment of any business process changes on existing controlled documents, including the Pharmacovigilance System Master File (PSMF)
Ensures the PSMF is maintained alongside, PSMF Sub-system files (PSSF) and summaries in accordance with Global, EEA and ex-EEA regulatory authority requirements
Manages the PSMF schedule and works with key PSMF contributors to ensure timely and accurate update and submission of the PSMF upon request
Creates/updates PV Agreement with PV partners and tracks compliance of PV team to the Agreements
Responsible for training matrices, schedules and curricula developed, implemented, and maintained across PV
Identifies and resolves non-compliance of PV, Vendors and Business partner staff for mandatory PV related training items on an ongoing basis
Collaborates with Deciphera QA to support the development and implementation of effective PV training compliance of stakeholders outside of PV
Contributes to the definition of measures used to assess the effectiveness of training programs
Develops, implements, and maintains a repository of PV staff member CVs, training records and job descriptions in collaboration with Deciphera QA policies, practices, and procedures
Ensures the continuous availability of all PV related documents, including but not limited to standards and procedures, governance meeting minutes, safety topic reviews/assessment reports and training content
Ensures integrity of PV internal repositories and conformance with Deciphera records retention policies
Ensures safety operations Distribution Lists (DL), mailboxes and other inbound communication channels are triaged and managed on an ongoing and timely basis as applicable
Supports the functioning of the office of the EU QPPV
Manages communication of regional QMS activities to functional areas and senior management
Supports data provisioning for benchmarking activities
Contributes to strategic initiatives across PV, as required
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