Global Drug Safety Specialist

Há 3 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$54.000 - R$78.000
Pharmacovigilance Role Overview

At the forefront of clinical development, our organization seeks a highly skilled Pharmacovigilance Assistant II to oversee the collection, processing, and timely reporting of adverse event reports. This role plays a vital part in ensuring regulatory compliance and data accuracy.

Key Responsibilities:
  • Collect, process, and report adverse event reports in accordance with regulatory requirements.
  • Maintain pharmacovigilance databases by accurately entering and reviewing reports for consistency and completeness.
  • Assist in preparing periodic safety reports, including risk-benefit analyses, for regulatory submissions and sponsors.
  • Collaborate with internal teams and external stakeholders to resolve queries related to safety data and pharmacovigilance activities.
  • Support audit and inspection readiness by maintaining comprehensive documentation of pharmacovigilance activities and safety reports.
Required Skills and Qualifications:
  • Bachelor's degree in life sciences, pharmacy, or a related field.
  • Previous experience in pharmacovigilance or drug safety, with a solid understanding of regulatory requirements and safety reporting processes.
  • Excellent attention to detail and strong organizational skills, with the ability to manage complex data sets and reports.
  • Strong communication and teamwork skills, with experience collaborating across cross-functional teams and external partners.
  • Ability to work in a fast-paced environment, ensuring compliance with regulatory guidelines and timelines.

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