Associate, Pharmacovigilance Specialist

hace 2 semanas


Ciudad de México, Ciudad de México AbbVie A tiempo completo
Job Summary

We are seeking a highly skilled Pharmacovigilance Associate to join our team at AbbVie. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the quality and integrity of our pharmacovigilance system.

Key Responsibilities
  • Metrics and Oversight: Develop and maintain local/regional procedures in line with corporate procedures and local requirements. Perform impact assessments of new/updated corporate policies, processes, and procedures.
  • Quality Management System: Actively assist with the PV Exception Reporting/CAPA process. Develop and maintain the local PSMF in line with AbbVie's PV system master file, when required by local/regional regulations.
  • ICSR Management: Record, process, and conduct follow-up and translate adverse events and other safety information from spontaneous and solicited sources. Perform ICSR expedited reporting according to local requirements.
  • Periodic Safety Reporting: Review periodic safety update reports (PSURs) for a determined TA or product to obtain information on the risk/benefit profile of products and share with the ARMT. Lead the preparation of periodic safety reports (e.g., PSUR).
  • Audits and Inspection Management: Actively assist in managing internal PV audits, audits of affiliate service providers/third parties, and Regulatory Authority PV Inspections.
Requirements
  • Bachelor's degree in a health/science discipline.
  • Minimum of 1 year of experience is desirable.
  • Good writing and oral skills in English and Spanish.
  • Computer proficient with Microsoft programs, particularly Word and Excel.
  • Ability to work with multiple priorities in a work environment with frequent interruptions.
  • Ability to perform teamwork.
About AbbVie

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. We are dedicated to creating a workplace where everyone feels valued, respected, and empowered to contribute their best work.



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