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Manager, DSPV Quality, Compliance & Training

Cambridge, MA

Posted: 04/03/2019 Employment Type: Direct Hire Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety Job Number: 2325

Our client is searching for an experienced Manager of (DSPV) Quality, Compliance and Training that is a creative, resourceful and integrative thinker. The manager will report to the Associate Director of PV Quality, Compliance and Training. This candidate will assist with the establishment and maintenance of the Global Quality System for DSPV that supports client’ s products in compliance with ICH Guidelines and international regulatory requirements. The successful candidate will have a proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency. Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Operations, Medical Science, Data Science, Regulatory Affairs and Quality Systems and Medical Affairs.

Role and Responsibilities:

Support for DSPV Controlled Documents
  • Actively support the development and revision of DSPV policies, SOPs and procedures that support the Quality System.
  • Work directly with the Associate Director of Compliance to build and maintain a process for tracking all DSPV controlled documents.
  • Assist with establishing procedures for documentation of department compliance and the development of quality assurance plans to improve or maintain data quality.

DSPV Compliance
  • Assist with monitoring the global DSPV Quality System through metrics and reports.
  • Utilizes PVQ to develop and generate metrics and reports for senior management.
  • Monitor compliance with worldwide regulations for the reporting of adverse events.
  • Monitor activities of CROs/business partners to ensure adherence and compliance with applicable SMPs, KPIs/Metrics, PVAs and other contractual agreements.

Support for Internal Audits and Health Authority Inspections
  • Participate in DSPV auditing and inspection activities of vendors and third parties in global territories as needed.
  • Work with the PV operations group to provide data requested by auditors.
  • Participate in inspection readiness activities as appropriate.
  • Support deviation documentation, training and CAPAs.
  • Assist with establishing an inspection readiness process for pharmacovigilance.
  • Assist with audit responses from Pharmacovigilance and external partners/vendors and evaluate proposed corrections, corrective actions, and/or preventative actions for compliance with applicable regulations, guidelines, and policies.

  • Assist with the development and implementation of a DSPV training program.
  • Monitor department adherence and compliance regarding training with SOPs, and other PV specific procedural documents.
  • Identify relevant quality-related training needs and conduct training as required.

Experience, Education and Specialized Knowledge and Skills:
  • Bachelor’ s degree in relevant field (e.g. Life sciences) or equivalent combination of education and experience.
  • 3-5 years’ experience in Pharmacovigilance compliance preferred.
  • Master’ s degree preferred.
  • Significant prior pharmaceutical or biotechnology drug development experience
  • Comprehensive knowledge of the international pharmacovigilance regulations and requirements, including European Medicines Agency (EMA) Good Pharmacovigilance Practices (GPV)
  • Prior experience managing quality and compliance activities
  • Excellent problem solving and analysis skills; ability to see trends and convert information to insights.
  • Ability to adapt precedent and develop creative and effective solutions to solve problems.
  • Must have experience in working with Pharmacovigilance and/or Pharmacovigilance processes.
  • Ideally have a working knowledge of Argus and PVQ
  • Prior training experience or the equivalent

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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