Pharmacovigilance Business Analyst Role
We are seeking a skilled Pharmacovigilance Business Analyst to join our team. As a key liaison between business users, regulatory teams, and IT, you will ensure that pharmacovigilance systems and workflows support accurate and compliant adverse event reporting.
This critical role is responsible for maintaining patient safety, regulatory compliance, and efficient safety operations.
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.
* 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.
Requirements:
* 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.
Desirable Skills:
* 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.
* Ability to use documentation and reporting tools to support system analysis and validation.