Job Title: Adverse Event Reporting Specialist
The Pharmacovigilance Business Analyst will play a vital role in maintaining patient safety and efficient safety operations. This position requires strong collaboration between business users, regulatory teams, and IT to ensure accurate and compliant adverse event reporting.
* Gather and analyze requirements for pharmacovigilance systems and workflows, ensuring seamless integration with existing processes.
* Work closely with stakeholders to implement or enhance safety systems, fostering a culture of continuous improvement.
* Document business processes, data flows, and system functionalities related to adverse event reporting, facilitating clear communication among team members.
Key Responsibilities:
- Ensure compliance with global regulatory standards, adhering to stringent guidelines and regulations.
- Support validation and user acceptance testing of PV systems, guaranteeing their accuracy and reliability.
- Provide comprehensive support and training to end-users on safety systems and processes, empowering them to excel in their roles.
Requirements:
- A degree in a relevant field, such as life sciences or business administration.
- In-depth knowledge of pharmacovigilance processes and regulatory requirements, staying up-to-date with the latest developments and trends.