Safety Process Specialist

Há 2 dias

Brasil beBeeCompliance Tempo inteiro R$90.000 - R$158.000

Job Opportunity: Pharmacovigilance Business Analyst

This position plays a pivotal role in ensuring adherence to international regulatory standards.

Key Responsibilities:

  • Collect and analyze requirements for pharmacovigilance systems and workflows.
  • Collaborate with business stakeholders, regulatory teams, and IT to implement or enhance safety systems.
  • Document business processes, data flows, and system functionalities related to adverse event reporting.
  • Guarantee compliance with FDA, EMA, and MHRA regulations.
  • Support validation and user acceptance testing of PV systems.
  • Offer support and training to end-users on safety systems and processes.

Requirements:

  • In-depth knowledge of pharmacovigilance processes and regulatory requirements.
  • Experience working with safety systems such as Argus, ArisG, and Veeva Vault Safety.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal abilities.
  • Ability to work collaboratively in cross-functional teams.

What We Offer:

A dynamic work environment that fosters collaboration and innovation.

How to Succeed:

Develop strong relationships with colleagues and stakeholders, effectively communicate complex ideas, and prioritize tasks to meet deadlines.

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