PV Compliance Specialist
GE
Oslo, Norway
4 dager siden

Essential Responsibilities

  • Participate in the development, implementation, and / or oversight of quality and compliance activities within Global PV Organization e.
  • g. develop SOPs, process maps and guidelines based upon regulations and strategies

  • Maintain a robust PV Quality System via compliance activities demands persistent critical attention, particularly in the areas of compliance and quality control
  • 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
  • Collaborate with cross functional subject matter experts to design and document processes and develop documentation
  • Work with Quality Assurance colleagues to perform reconciliation for product complaints
  • Identify noncompliance and contribute to the investigation and development of corrective and preventive action plans
  • Ensure the department’s compliance with various third-party agreements (distributor, contractor, collaborative partners) and track safety data exchange information to ensure compliance with SDEA parameters
  • Provide support as needed for project management activities and support during audits and inspections
  • Role Summary / Purpose

    We are looking for you to join our global team in Oslo! In this role as Pharmacovigilance Compliance Specialist you will conduct and / or support a wide range of moderate to sometimes multifaceted scope and complex pharmacovigilance activities on an individual basis working within established timeframes and ensuring compliance with global and local procedures, policies, processes and guidelines.

    Qualifications / Requirements

  • Bachelor of Science degree as Registered Nurse or Pharmacy degree preferred
  • Minimum of 2 years in Pharmacovigilance in a Pharma / Biotech company, including clinical trials and post-marketing experience doing data entry and reporting of ICSRs
  • Experience with project coordination in relevant industries
  • Working knowledge of Global Pharmacovigilance Regulations and associated compliance monitoring as well as ICH guidelines
  • Proficiency working in Microsoft-based word processing and spreadsheet applications
  • Fluent verbal and written skills in English
  • Desired Characteristics

  • High integrity, sense of urgency, ability to recognize time sensitivity
  • Ability to communicate effectively in a matrix environment
  • Sound attention to detail
  • Strong sense of responsibility and an ability to work independently as well as in a team
  • Understands established procedures and communicate those procedures to others
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