Job Title: Pharmacovigilance Business Analyst
Job Description
The Pharmacovigilance Business Analyst plays a pivotal role in ensuring patient safety, regulatory compliance, and efficient operational processes. As a liaison between business users, regulatory teams, and IT departments, this position requires strong analytical and problem-solving skills to drive key projects forward.
Key Responsibilities:
* Gather and analyze requirements for pharmacovigilance systems and workflows to optimize performance and efficiency.
* Collaborate with cross-functional teams to implement or enhance safety systems, ensuring alignment with global regulatory standards.
* Document business processes, data flows, and system functionalities related to adverse event reporting to facilitate seamless operations.
* Ensure ongoing compliance with evolving global regulatory requirements.
* Support validation and user acceptance testing of PV systems to guarantee quality and efficacy.
* Provide comprehensive training and support to end-users on safety systems and processes to foster a culture of continuous learning.
Required Skills and Qualifications
* Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, IT) with a strong foundation in pharmacovigilance principles and practices.
* In-depth knowledge of pharmacovigilance processes, regulatory requirements, and industry trends.