The Pharmacovigilance Business Analyst role plays a vital part in upholding patient safety and regulatory compliance while ensuring efficient operational workflows.
This position serves as a key liaison between business stakeholders, regulatory teams, and IT to guarantee that pharmacovigilance systems and processes support accurate and compliant adverse event reporting.
Key Responsibilities:
* Collect and analyze requirements for pharmacovigilance systems and workflows.
* Collaborate with business stakeholders, regulatory teams, and IT to implement or enhance safety systems.
* Document business processes, data flows, and system functionalities related to adverse event reporting.
* Evaluate compliance with global regulatory standards (e.g., FDA, EMA, MHRA).
Required Skills and Qualifications:
* 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.
Familiarity with Tools and Technologies:
* Pharmacovigilance safety systems such as Argus, ArisG, and Veeva Vault Safety.
* Adverse event reporting workflows and compliance processes.
Desirable Skills:
* Certification in pharmacovigilance.