Pharmacovigilance Compliance Specialist

General Electric - Marlborough, MA4.1

Full-time
Role Summary:
Maintaining a robust PV Quality System via compliance activities demands persistent critical attention, particularly in the areas of compliance and quality control. PV regulations are becoming more stringent worldwide. The PV Compliance Specialist conducts and/or supports a wide range of moderate to multifaceted scope and complex pharmacovigilance activities, while working within established timeframes and ensuring compliance with global and local procedures, policies, processes and guidelines.

Essential Responsibilities:
Essential Responsibilities

  • Participate in the development, implementation, and/or oversight of quality and compliance activities within Global PV Organization.
  • Develop and assist with activities related to Individual Case Safety Report (ICSR) Quality Review in which selected cases can be reviewed against source documents and any quality findings are documented and tracked for training and trending purposes.
  • Perform Quality Control assessments of PV activities such as case processing, including the verification of documents in the safety database. Quality findings should be documented for tracking and trending purposes and findings will be discussed internally on a regular basis.
  • Work closely with PV Compliance Leads to ensure global PV Network contacts, local training, assisting in new staff onboarding initiatives and local reporting requirements are accurate and up-to-date at all times.
  • Perform monthly reconciliation of safety tracking logs of AE reports sent from the PV network to the Central Safety Unit and Global Regulatory Agencies, archiving all correspondences appropriately and according to good documentation practices.
  • Work with Quality Assurance colleagues to perform reconciliation for product complaints
  • Ensure the department’s compliance with various third-party agreements (distributor, contractor, collaborative partners) Track safety data exchange information to ensure compliance with SDEA parameters
  • Identify noncompliance and contribute to the investigation and development of corrective and preventive action plans
  • Provide support as needed during audits and inspections
  • Other responsibilities for this role may include, but not limited to, safety reconciliation efforts, consisting of documentation and monitoring of safety information exchange throughout the global PV network (Local Safety Units (LSUs) and distributors) to ensure the receipt and reporting to the GEHC Central Safety Unit (CSU) and global regulatory agencies in compliance with PV SOPs and global regulatory requirements
Qualifications/Requirements:
  • Bachelor of Science degree with minimum of 4 years experience
  • Minimum of 2 years in pharmaceutical/biotechnology industry experience in PV, including clinical trials
and post-marketing experience doing data entry and reporting of ICSRs.
  • Global experience and experience in Pharmacovigilance compliance monitoring is preferred.
  • Proficient in US/EU/AP/LA regulations and ICH guidelines. Working knowledge of Global Pharmacovigilance Regulations and associated compliance monitoring
  • Proficiency working in Microsoft-based word processing and spreadsheet applications
Desired Characteristics:
  • RN or Pharmacy Degree preferred
  • High integrity, sense of urgency, ability to recognize time sensitivity
  • Ability to communicate effectively in a matrix environment
  • Ability to multi-task
  • Solid written and oral communication skills
  • Sound attention to detail
  • Strong sense of responsibility and an ability to work autonomously, as well work in a team setting
  • Strong understanding of general Pharmacovigilance concepts and practices
  • Understands established procedures and communicate those procedures to others
  • Performs other duties as assigned
About Us:
There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than
11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE
Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the
journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge
technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future.
We are accelerating biology to cell therapy in ways no other company can.
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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.

Locations: United States; Massachusetts; Marlborough
GE will only employ those who are legally authorized to work in the United States for this opening.