Job Title: Pharmacovigilance Business Analyst
The role of a Pharmacovigilance Business Analyst is pivotal in bridging the gap between business stakeholders, regulatory teams, and IT departments. The primary responsibility of this position is to ensure that pharmacovigilance systems and workflows are aligned with regulatory requirements for accurate and compliant adverse event reporting.
This position plays a crucial role in maintaining patient safety, adhering to regulatory compliance, and optimizing safety operations. To achieve this, the incumbent must possess exceptional analytical and problem-solving skills, coupled with excellent communication and interpersonal abilities.
* Gather and analyze requirements for pharmacovigilance systems and workflows to ensure seamless integration and compliance.
* Collaborate with cross-functional teams to implement or enhance safety systems, ensuring adherence to global regulatory standards.
* Develop and maintain documentation on business processes, data flows, and system functionalities related to adverse event reporting.
* Ensure validation and user acceptance testing of PV systems to guarantee accuracy and efficiency.
* Provide training and support to end-users on safety systems and processes to optimize their understanding and utilization.
* Bachelor's degree in Life Sciences, Pharmacy, or a relevant field.
* In-depth knowledge of pharmacovigilance processes and regulatory requirements.
* Hands-on experience with safety systems such as Argus, ArisG, Veeva Vault Safety.
* Strong analytical and problem-solving skills, with ability to work effectively under pressure.
* Excellent communication and interpersonal abilities, with a focus on collaboration and stakeholder engagement.
* Certification in pharmacovigilance.
* Experience with validation and user acceptance testing of PV systems.
* Familiarity with pharmacovigilance safety systems.
* Understanding of adverse event reporting workflows and compliance processes.
* Global pharmacovigilance regulations.