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Regulatory Compliance Officer

hace 2 semanas

Buenos Aires, Buenos Aires C.F., Argentina IQVIA A tiempo completo

About the Role

We are seeking a highly skilled Regulatory Compliance Officer to join our team at IQVIA. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements, Standard Operating Procedures (SOPs), and internal guidelines.

Main Responsibilities

  • You will process safety data according to applicable regulations, guidelines, SOPs, and project requirements.
  • Pharmacovigilance activities, including collecting and tracking incoming Adverse Events (AEs) and endpoint information, determining initial/update status of incoming events, database entry, coding AEs and products, writing narratives, and literature-related activities, will be your responsibility.
  • Ensuring compliance with quality, productivity, and delivery standards per project requirements is essential.
  • Liaising with different functional team members and healthcare professionals to address project-related issues is also key.
  • Mentorship of new team members and support for department initiatives as assigned by the manager is expected.

Qualifications

  • A Bachelor's degree in life sciences or a related field is required.
  • Up to 3 years of relevant experience, including up to 1 year of pharmacovigilance experience, is valuable.
  • Fluency in English, Spanish, and Portuguese is necessary.