Drug Safety Associate I
4 weeks ago
Job Summary
The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
Key Responsibilities
- Design, develop, and maintain Power BI reports and dashboards without/with Data extract from Veeva Vault RIM for enterprise-wide users.
- Work closely with business users, business analysts, data engineers, and stakeholders to gather requirements and translate them into technical solutions.
- Analyze complex business and operational system requirements and recommend solution options.
- Integrate data from various sources into Power BI using SQL queries, SharePoint, and Dataflows to provide comprehensive insights.
- Write and optimize SQL queries to extract and manipulate data for reporting purposes.
- Participate in meetings and discussions to understand business needs and provide technical insights.
- Stay updated with the latest developments and best practices in Power BI, SQL, and Power Platform.
- Propose and implement improvements to existing reports, dashboards, and processes.
- Responsible to support the production environment to assist the business users for any issues related to data and reporting.
- Experienced in the management of the regulatory information of Medicinal Products/Vaccines/Devices/Nutraceuticals which includes performing the data entry in the Veeva Vault.
- Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
- Assist in development of project specific safety procedures, workflows and template.
- Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing.
- Data entry of case reports into safety database / tracking system.
- Request follow-up and perform query management.
- Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as required.
- Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects.
- Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities.
- Participate in client and investigator meetings as required.
- Attend internal, drug safety and project specific training sessions.
- Perform literature searches.
- Preparation for, participation in, and follow up on audits and inspections.
- Delegate work as appropriate to Drug Safety Assistants.
- Assistance in development of Expedited Reporting Procedures.
- Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor.
- Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy).
- Submission of safety reports to investigators via ISIS (International Safety Information System).
- Assist with measuring investigative site performance in conducting required tasks in ISIS.
- Tracking and filing of submission cases as required.
- Assist with unblinding of SUSARs, as required.
- Support collection and review of metrics for measuring reporting compliance.
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