SAWSANH AL-OGAIDI

Motivated Clinical Research Coordinator and licensed pharmacist seeking to transition into Drug Regulatory Affairs or Pharmacovigilance. Backed by 3+ years of hands-on experience in clinical trials, AE/SAE documentation, and regulatory compliance, and currently pursuing an M.Sc. in Drug Regulatory Affairs. Eager to apply clinical insight and regulatory training to support product lifecycle management, safety reporting, and compliance with EU and international standards.

• - Drug Regulatory Affairs (National, DCP, MRP, CP): Gained through M.Sc. Drug Regulatory Affairs – Modules 1, 2, 3, 4 and hands-on dossier preparation training.
• - Pharmacovigilance & Risk Assessment: Applied during role as Clinical Research Coordinator at HELIOS; formal foundation from Module 5 of M.Sc. program.
• - Clinical Trial Coordination (Phase I–IV): Executed at HELIOS University Hospital across multiple trials; theory covered in Module 3.
• - Regulatory Writing (eCTD, DSUR, PSUR, ICF): Performed at HELIOS and covered in-depth in Modules 4, 5, and 6 of the M.Sc. program.
• - GxP Compliance (EU-CTR, ICH-GCP, GVP, GMP): Operationalized in clinical coordination at HELIOS; covered across Modules 2, 5, and 7.
• - Signal Detection & Risk Management Plans: Implemented during pharmacovigilance duties at HELIOS; reinforced in Module 5.
• - CAPA Tracking & Audit Readiness: Managed post-inspection CAPAs at HELIOS; principles taught in Module 7 (Quality Management).
• - Tools: CTMS, EDC, RedCap, MedDRA, WHO-DD: Used extensively during clinical trials at HELIOS; supported by technical workshops in Module 6.