Raj Kaur

Oversee due diligence and safety mailbox activities, manage SUSAR and DSUR submissions to Health Authorities and Ethics Committees, and lead vendor compliance and CAPA processes to maintain regulatory compliance and team quality.

Performed daily ISCR monitoring, conducted due diligence for follow-up from reporters, and managed reconciliation activities with vendors to ensure timely and accurate safety reporting.

Maintained case documentation, reported safety information to investigators, ethics committees and MHRA, and managed AE report tracking and customer follow-up during MHRA inspection-related projects.

Processed safety cases, responded to internal and external enquiries, collaborated with Medical Information, and monitored team mailbox to support local drug safety operations during departmental change.

Processed and assessed CNS clinical and spontaneous reports, performed manual labelling and QC, mentored new starters, and covered team lead duties to improve case quality and meet deadlines.

Conducted quality review of a large case backlog, performed reconciliation of study data, and recommended workflow improvements to streamline pharmacovigilance processes.

Reviewed and coded adverse event data using MedDRA, coordinated follow-up and routine reporting, trained new starters, and led licensing duties across four sites to ensure Safety Data Exchange Agreement compliance.

Reviewed clinical data, generated and resolved queries, performed data quality checks and supported database lock activities while mentoring new team members.

Completed a Bachelor of Science (Hons) in Medical Biochemistry, covering core biochemical and medical laboratory techniques.

Grade: Biology: B; Physics: C; Chemistry: D

Studied A-Levels in Biology, Physics and Chemistry, achieving grades B, C and D respectively.