Pharmacovigilance Business Analyst Role Overview
The Pharmacovigilance Business Analyst will serve as a key liaison between business users, regulatory teams and IT ensuring that pharmacovigilance systems and workflows support accurate and compliant adverse event reporting.
Key Responsibilities:
* Gather and analyze requirements for pharmacovigilance systems and workflows.
* Work 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.
* Support validation and user acceptance testing of PV systems.
* Provide support and training to end-users on safety systems and processes.
Qualifications:
* Bachelor's degree in a relevant field.
* 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.