Expert Pharmacovigilance Operations Specialist

1 dia atrás

Brasil beBeeRegulatory Tempo inteiro R$67.544 - R$97.889

Job Title: Pharmacovigilance Business Analyst

This role plays a crucial part in ensuring patient safety, regulatory compliance, and efficient operations.

  • Gathers and analyzes system requirements to ensure seamless pharmacovigilance workflows.
  • Collaborates with cross-functional teams to implement or enhance safety systems.
  • Ensures adherence to global regulatory standards such as FDA, EMA, and MHRA.
Key Responsibilities:

Document business processes, data flows, and system functionalities related to adverse event reporting.

  • Support validation and user acceptance testing of PV systems.
  • Provide training and support to end-users on safety systems and processes.
Requirements:

Essential Qualifications:

  • Bachelor's degree in a relevant field such as Life Sciences, Pharmacy, or IT.
  • Extensive knowledge of pharmacovigilance processes and regulatory requirements.
  • Experience working with safety systems such as Argus, ArisG, and Veeva Vault Safety.
Desirable Skills:

Additional Qualifications:

  • Certification in pharmacovigilance.
  • Experience with validation and user acceptance testing of PV systems.
Tools and Technologies:

Technical Expertise:

  • Hands-on experience with pharmacovigilance safety systems such as Argus, ArisG, and Veeva Vault Safety.
  • Familiarity with adverse event reporting workflows and compliance processes.

This position requires strong analytical skills, excellent communication, and the ability to work collaboratively in cross-functional teams. It is a remote position that offers flexibility and opportunities for growth.

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