Senior Safety Operations Specialist

Há 13 horas

Sorocaba, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$120.000 - R$160.000
Job Title: Pharmacovigilance Business Analyst

The role of a Pharmacovigilance Business Analyst is multifaceted, involving the maintenance of patient safety, regulatory compliance, and efficient safety operations.

Key Responsibilities:
  • Gathering and analyzing requirements for pharmacovigilance systems and workflows.
  • Implementing or enhancing safety systems such as Argus, ArisG, and Veeva Vault Safety.
  • Documenting business processes, data flows, and system functionalities related to adverse event reporting.
  • Ensuring compliance with global regulatory standards (e.g., FDA, EMA, MHRA).
  • Supporting validation and user acceptance testing of PV systems.
  • Providing support and training to end-users on safety systems and processes.
  • Collaborating with cross-functional teams including regulatory affairs, clinical operations, and IT.
Required Skills and Qualifications:
  • Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, IT).
  • In-depth knowledge of pharmacovigilance processes and regulatory requirements.
  • Experience working with safety systems such as Argus, ArisG, Veeva Vault Safety.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal abilities.
  • Ability to work collaboratively in cross-functional teams.
  • Certification in pharmacovigilance.
  • Experience with validation and user acceptance testing of PV systems.
Tools and Technologies:
  • Hands-on experience with pharmacovigilance safety systems such as Argus, ArisG, and Veeva Vault Safety.
  • Familiarity with adverse event reporting workflows and compliance processes.
  • Understanding of global pharmacovigilance regulations (e.g., FDA, EMA, MHRA).
  • Ability to use documentation and reporting tools to support system analysis and validation.

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