Pharmacovigilance Business Analyst Job Description
Key Responsibilities:
* Gather and analyze business needs for pharmacovigilance systems and workflows.
* Work with stakeholders, 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 (e.g., FDA, EMA).
* 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).
* In-depth knowledge of pharmacovigilance processes and regulatory requirements.
* Experience working with safety systems such as Argus, ArisG.
* Strong analytical and problem-solving skills.
* Excellent communication and interpersonal abilities.
Benefits:
* Hands-on experience with pharmacovigilance safety systems.
* Familiarity with adverse event reporting workflows and compliance processes.
* Understanding of global pharmacovigilance regulations.
Additional Information:
* Collaborate with cross-functional teams including regulatory affairs, clinical operations, and IT.
* Ability to use documentation and reporting tools to support system analysis and validation.