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Manager - Drug Safety and Pharmacovigilance Quality & Compliance

Cambridge, Massachusetts 02142

Post Date: 02/14/2018 Job ID: 1766 Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety

The Drug Safety & Pharmacovigilance Department (DSPV) Q&C Manager is responsible for supporting the DSPV Quality & Compliance activities based on relevant regulations, procedures, and contractual requirements.   Through implementation of quality and compliance tracking tools, oversight strategy and relationship management, this role will support the management of all DSPV SOPs, CAPAs and inspection related activities, as well as leading a QC system for all DSPV documents.   The DSPV Q&C Manager will manage a global DSPV training program, including the implementation, tracking, maintenance, and effectiveness checking of all DSPV training activities. The incumbent will support the organization and maintenance of a DSPV compliance system with metrics.

Job  Responsibilities: 
  • Support DSPV process improvements including authoring controlled procedures, maintaining the DSPV procedures Index, leading meetings of subject matter experts to revise procedures and merge procedures, to reduce the total number of procedures for improved efficiency, where possible
  • Maintain the DSPV project tracking tool for quality and compliance oversight
  • Participate in Pharmacovigilance Agreement creation and revision
  • Support DSPV quality system, which includes supporting the management of all DSPV SOPs, CAPAs, and inspection related activities, as well as a QC system for all DSPV documents
  • Support the development and management of a quality system for DSPV documents including ICSRs, PSUR, DSURs, ad hoc reports, compliance and performance metrics, alliance management and signal detection activities
  • Help to ensure the development, effectiveness evaluations, and compliance with DSPV SOPs.  Where there is cross-reference and/or cross functionality with other functional controlled procedures, ensure DSPV SOP alignment
  • Support Research Quality Assurance (RQA) by engaging and providing support of the RQA pharmacovigilance/clinical safety audit plan, compliance, audit and inspection activities, inspection readiness and other cross functionality
  • Serve as the primary point of contact for DSPV controlled documents (i.e. SOPs, WIs, etc.) and DSPV training and as the subject matter expert for these topics during audits and inspections
  • Monitor global pharmacovigilance regulatory intelligence to determine impact on pharmacovigilance quality system
  • Assist in monitoring DSPV commitments from internal audits, regulatory inspection findings, and CAPAs
  • Make contributions to the PV System Master File (PSMF) to ensure it is maintained on a regular basis
  • Contribute to the collection, organization, and presentation of all required global DSPV compliance metrics including vendor and partner oversight metrics
  • Lead and support the development and implementation of the global DSPV training strategy (training matrix development, process, content, delivery, system, tracking, metrics)
  • Lead and support the development, delivery, implementation, maintenance, and tracking of all DSPV training materials including tests for verification of training completion and effectiveness
  • Develop methods to determine the effectiveness of DSPV training and initiate improvements as required
  • Represent DSPV training on cross-functional learning initiatives and partner with related departments (Learning & Development, IT, Commercial Training, etc.) accordingly
  • Support the development, design & maintenance of compliance metrics, CAPA management for DSPV business process, and monitoring of trends with proposed remediation actions
  • Lead and Support DSPV compliance and alliance activities
  • Assist in DSPV preparation and inspection activities during Regulatory Agency inspections and internal audits
  • Remain current with global pharmacovigilance regulations and requirements, evaluate legislative changes affecting DSPV, and develop strategies to support the patient safety at the local level
  • Lead projects related to DSPV quality, training, and compliance activities, provide DSPV compliance and alliance advice and visibility to the company

Qualifications/ Requirements: 
  • Bachelor’ s Degree or equivalent work experience in a scientific or technical discipline
  • Must have a minimum of 5+ years of experience in the areas of GXP regulations with
  • 3-5+ years of experience in a quality and compliance role within pharmacovigilance highly preferred
  • Demonstrated analytical and process skills and the ability to apply these skills to PV organization
  • Analyze and interpret regulations and laws and apply to current and future policies and procedures (may include collaboration with other cross functional areas)
  • Global mindset required

Denise Kowalski
Clinical Recruiter

Denise is a focused, relationship-driven individual who brings creative energy and an eagerness to conquer new challenges to her role. A passionate life-long learner, Denise’s excellent communication skills, strong work ethic, and genuine interest in helping others make her a valuable asset to the Clinical team.

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