Safety Systems Specialist

1 dia atrás

Porto Alegre, Rio Grande do Sul, Brasil beBeeBusiness Tempo inteiro R$60.000 - R$90.000
Job Title: Pharmacovigilance Business Analyst

This is a remote opportunity to work with our team at hyqoo. The job duration is 6 to 12 months with the possibility of extension or conversion to full-time employment after 6 months.

Key Responsibilities:
  • Collect and analyze requirements for pharmacovigilance systems and workflows.
  • Collaborate with business users, regulatory teams, and IT to implement or enhance safety systems such as Argus, ArisG, and Veeva Vault Safety.
  • Document business processes, data flows, and system functionalities related to adverse event reporting.
  • Ensure compliance with global regulatory standards such as FDA, EMA, and MHRA.
  • Support validation and user acceptance testing of PV systems.
  • Provide support and training to end-users on safety systems and processes.
  • Work collaboratively with cross-functional teams including regulatory affairs, clinical operations, and IT.
Required Skills:
  • 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.
Desirable Skills:
  • Certification in pharmacovigilance.
  • Experience with validation and user acceptance testing of PV systems.
Education Qualification:
  • Bachelor's degree in a relevant field such as Life Sciences, Pharmacy, or IT.

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