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Director, Pharmacovigilance Compliance

Cambridge, MA 02142

Post Date: 08/10/2018 Job ID: 2096 Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety
Pharmacovigilance (PV) Compliance is a senior PV leader and creative and resourceful thinker. The Director will establish and maintain a Compliance and PV Quality System in accordance with international regulations and guidelines. He/she must be proactive, hands-on with a sense of urgency.

Responsibilities:
  • Establish Metrics and other monitoring systems to measure and verify compliance for senior management.
  • Leads PV inspection readiness activities and coordinates for global inspection readiness.
  • Maintain and update the PSMF with QPPV and Head of PV.
  • Develop and maintain a PV Quality System for Standard Operating Procedures, auditing, CAPAs.
  • Assisting in the development, implementation and management of a PV training program.
  • Work with Quality Assurance and other functions to establish pharmacovigilance activities in the company.
  • Identify gaps in Pharmacovigilance, solutions, and monitor completion.
  • Develop with SMEs and maintain SOPs.
  • Develop and maintain Pharmacovigilance Agreements and Safety Data Exchange Agreements. Monitor compliance with required activities according to executed agreements.
  • Monitor aggregate/periodic report compliance, reconciliations; monitor quality, timeliness and performance; assist in process.
  • Manage EEA QPPV and local QPPV communication, etc.
  • Manage training and documentation for PV department and PV training company-wide, vendors, etc.


Requirements:
  • Bachelor’ s or Master’ s Degree in Health or Medical sciences, degree in Pharmacy, Nursing or Public Health a plus
  • 5-10 years experience in Drug Safety / Pharmacovigilance with at least 3 year compliance experience preferred
  • Global PV regulation experience is preferred.
  • Ability to maintain positive relationships with management, peers and cross-functional departments
  • Traits include critical thinking, sense of urgency, diplomacy and professionalism.
  • Recognized by former peers, colleagues, managers and direct reports for attributes congruent with

Lisa Madden
Recruiting Consultant

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