Skills

IQVIA - Pharmacovigilance Operations Specialist – Regulatory Reporting 24th Sep 2018 – Present • Assigned as Regulatory Lead and Back-Up Regulatory Lead for multiple projects. • Assigned as Regulatory Lead for Start-Up Project which involved setting up the project, liaising with different functional team members, liaising with client in relation to details on day to day process of cases, Performing UAT Testing and Configuration Validation of the safety database. • Achieved QC Qualification to perform Quality Control checks on various safety activities such as data entry and regulatory submissions performed by other team members. • Leading by example, providing training and mentoring for less experienced team members and operations staff. Assisting Operations with appropriate allocation of resources. • Processing Lifecycle Safety (LCS) data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements and reporting to regulatory authorities (RA), ethics committees, institutional review boards, and investigators per legislation and within timelines. • Receiving and documenting incoming SUSAR, DSUR and PSUR Reports, telephone calls, faxes or emails from investigative sites or other sources reporting LCS data. Submitting these reports to RAs according to FDA, EMA and country specific regulatory requirements. • Ensuring Good Clinical Practise and Good Pharmacovigilance Practise within the department. • Generating status reports, providing project metrics, drafting project instructions/guidelines and assisting in the implementation of new processes and reporting this to the client. • Investigating and reporting NCOs (Non-compliance Occurrence) and SUDRs (Significant Unplanned Deviation Report). Conducting Root Cause Analysis and CAPAs. • Ensuring compliance to IQVIA high quality standards and achieving project and customer deliverables. • Achieving operational departmental goals i.e. understanding metrics appropriate to quality document management and assist in the achievement of productivity utilization and realization metrics. • Reading and acknowledging all necessary IQVIA and customer SOPs. Ensuring all required training is executed and documented.

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