Operational Safety Specialist
At our organization, we combine innovation with compassion to improve lives globally.
We seek individuals who are dedicated to making a positive impact on the world.
Our team is comprised of over 1,600 employees from diverse backgrounds who deliver innovative solutions across various functions including Finance, IT, Medical, Clinical Trials and more.
Our Little Island campus offers flexible hybrid working options, comprehensive benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.
Our People Development services, Educational Assistance, and wellbeing initiatives enhance the career experience for our colleagues.
We promote inclusion by catering to all dimensions including ethnicity, nationality, cultural background, generation, sexuality, visible and invisible disabilities, and gender.
Key Responsibilities:
* Apply clinical judgment, critical thinking, and regulatory knowledge to manage adverse event data within GPS systems ensuring data integrity, consistency, and compliance.
* Expand knowledge of compounds/products including design of clinical trials, safety profile, regulatory commitments, indications, identified risks, main adverse reactions, risk minimization activities.
* Expand regulatory expertise on case collection and expedited reporting requirements dictated by major regulatory agencies.
* Partner with other GPS areas and clinical functions to maintain EPM and late phase clinical trials information.
* Prepare serious adverse event forms for clinical trials and provide testing assistance for Inform studies.
* Provide expertise related to data collection activities and configuration to ensure data integrity through the data flow.
* Support configuration of safety data collection modules for cross-functional platforms.
* Understand functioning of systems owned GPS and contribute to updates/enhancements and solution of workflow issues.
Quality, Compliance, and Operational Oversight
* Ensure that adverse event data is managed appropriately to internal standards and external regulations.
* Conduct quality assessments defined in prevailing procedures and drive quality initiatives.
* Lead/support quality control activities such as deviation identification, documentation, and CAPA management.
* Review and analyze individual adverse event reports to establish need to report to regulatory authorities.
* Act as subject matter expert for creation, revision, and maintenance of procedures and resources.