Job Overview
The Pharmacovigilance Business Analyst plays a pivotal role in ensuring patient safety and regulatory compliance.
Key Responsibilities:
* Gather and analyze pharmacovigilance system requirements
* Collaborate with stakeholders to implement or enhance safety systems
* Document business processes, data flows, and system functionalities related to adverse event reporting
* Evaluate global regulatory standards such as FDA, EMA, and MHRA for compliance
* Support validation and user acceptance testing of PV systems
* Provide training and support on safety systems and processes
Required Skills and Qualifications:
* Bachelor's degree in Life Sciences, Pharmacy, or IT
* In-depth knowledge of pharmacovigilance processes and regulatory requirements
* Experience working with safety systems like Argus, ArisG, and Veeva Vault Safety
* Strong analytical and problem-solving skills
* Excellent communication and interpersonal abilities
Why Join?
This is an exciting opportunity to contribute to the advancement of patient safety and make a meaningful impact in the industry.