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Pharmacovigilance (PV) Compliance & Training Leader

  • GE Healthcare
  • Experienced
  • Posted 1/24/2017 4:12:09 PM
  • 2826690
  • Job Function: Quality
  • Business Segment: Healthcare Life Sciences
Location(s): United States ; Massachusetts; Marlborough


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Life Sciences

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Role Summary:
The Pharmacovigilance (PV) Compliance & Training Leader will assist the Head of Global Pharmacovigilance Compliance and Training in day to day global compliance activities.

Essential Responsibilities:

  • The PV Compliance and Training Leader will assist the Head of Global PV Compliance and Training in all aspects of maintaining a global PV quality system including Standard Operating Procedures, quality documents, compliance measures, audit/inspection readiness and training
  • Serve as a liaison between Central Safety Unit (CSU) and Global PV network including Local Safety Units (LSUs), distributors, wholesalers and partners
  • Provide PV training to Global PV Network (LSUs, distributors and partners)
  • As needed, provide PV training to GEHC employees or those working on behalf of GEHC
  • Perform ongoing monitoring of compliance, metrics and performance data
  • Provide detailed root cause analysis of non-compliant single case reports (late cases) and aggregate reports
  • Serve as key resource person in inspections and audits
  • Perform reconciliation of safety information including AE tracking logs from PV network and reconciliation for product quality complaints
  • Perform quality assurance, report achieved quality levels and recommend revision of quality documents, user guides and training materials
  • Collaborate with internal and external partners on issues and activities related to quality, compliance and case processing activities
  • Interpret and apply changing global regulations and guidance pertaining to product safety and pharmacovigilance (clinical and post marketing)
  • Participate in teams and committees as assigned
  • Ability to travel to other locations for PV meetings, trainings


Quality Specific Goals:

  • Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and
    regulations as they apply to this job type/position
  • Complete all planned Quality & Compliance training within the defined deadlines
  • Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Knowledge and understanding of GEHC MD QS
    on Pharmacovigilance and the Global Pharmacovigilance procedures


Qualifications/Requirements:

  • RN, NP or PharmD degree with clinical experience
  • Minimum of 6 years of pharmaceutical/biotechnology industry experience in PV including clinical trial and post-marketing. Global experience preferred.
  • At least 4 years of pharmacovigilance quality management experience
  • Demonstrated mastery of the activities and processes related to single case processing and aggregate reporting. Signal detection and risk management experience helpful
  • Prior regulatory inspections experience
  • Proficient in US/EU/AP/LA regulations and ICH guidelines
  • Exposure to working relationship with FDA and other regulatory authorities
  • Strong oral and written communication and interpersonal skills
  • Ability to travel domestically or internationally up to 10% of the time


Desired Characteristics:

  • Ability to work with interdisciplinary, highly matrixed teams
  • Global experience preferred


Locations: United States ; Massachusetts; Marlborough

GE offers a great work environment, professional development, challenging careers, and competitive compensation.  GE is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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