Pharmacovigilance is a critical component of modern healthcare. The successful Pharmacovigilance Specialist will serve as a key liaison between business stakeholders, regulatory teams, and IT to ensure pharmacovigilance systems and workflows support accurate and compliant adverse event reporting.
This role is pivotal in maintaining patient safety, regulatory compliance, and efficient safety operations. The specialist will collaborate with cross-functional teams to gather requirements, implement solutions, and provide support for pharmacovigilance systems such as Argus, ArisG, and Veeva Vault Safety.
Key Responsibilities:
* Gather and analyze requirements for pharmacovigilance systems and workflows.
* Work with stakeholders, regulatory teams, and IT to develop or enhance safety systems.
* Document business processes, data flows, and system functionalities related to adverse event reporting.
* Evaluate compliance with global regulatory standards.
* Support validation and user acceptance testing of PV systems.
* Provide training and support to end-users on safety systems and processes.
Qualifications:
* Bachelor's degree in a relevant field such as life sciences or healthcare administration.
* In-depth knowledge of pharmacovigilance processes and regulatory requirements.
* Experience working with safety systems including Argus, ArisG, and Veeva Vault Safety.
* Strong analytical and problem-solving skills with attention to detail.
* Excellent communication and interpersonal abilities with ability to collaborate across teams.