Job Description
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 is critical in maintaining patient safety, regulatory compliance, and efficient safety operations.
* Gathering and analyzing requirements for pharmacovigilance systems and workflows is a primary responsibility of this role.
* Working with business users, regulatory teams, and IT to implement or enhance safety systems such as Argus, Arisg, Veeva Vault Safety is essential.
* Documenting business processes, data flows, and system functionalities related to adverse event reporting is necessary.
* Ensuring compliance with global regulatory standards such as FDA, EMA, and MHRA is crucial.
Required Skills and Qualifications
* A Bachelor's degree in Life Sciences, Pharmacy, or IT is required.
* In-depth knowledge of pharmacovigilance processes and regulatory requirements is essential.
* Experience working with safety systems such as Argus, Arisg, and Veeva Vault Safety is necessary.
* Strong analytical and problem-solving skills are required.
* Excellent communication and interpersonal abilities are essential.