Job Title: Pharmacovigilance Business Analyst
About the Role:
* We are seeking a skilled professional to fill this role.
* The successful candidate 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.
Main 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.
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.
* Familiarity with adverse event reporting workflows and compliance processes.
Key Qualifications:
* Degree in Life Sciences, Pharmacy, or IT.
* Pharmacovigilance certification is highly desirable.
Key Technologies:
* Proficient in using pharmacovigilance safety systems.
* Familiarity with adverse event reporting and compliance processes.