General Electric Pharmacovigilance Compliance Specialist in Marlborough, Massachusetts
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. This role will conduct and support a wide range of moderate to multifaceted scope and complex pharmacovigilance activities on an individual basis within established timeframes, ensuring compliance with global and local procedures, policies, processes and guidelines.
• Responsibilities for this role include 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
• Participate in the development, implementation, and/or oversight of quality and compliance activities within Global PV Organization.
• 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
• Under direction of the compliance leads, may be asked to perform Quality Control assessments of PV activities such as case processing, including the verification of documents in the safety database
• May 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
• Provide support as needed for project management activities and support during audits and inspections
• Bachelor of Science degree with RN or Pharmacy Degree preferred and/or 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.
• Prior experience in pharmacovigilance and/or regulatory affairs
• Experience from similar positions with project coordination in relevant industries
• 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
• Must be permitted to work in USA
• Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background
• 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
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GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.pdf . Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any 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.