Safa Louhichi

Therapeutic Areas: Oncology, Rheumatology

• Authored a Phase 3 efficacy CSR, interpreting and presenting clinical endpoints, statistical outputs and TLF data in a clear, regulatory-aligned narrative taken through full review cycles to submission-ready stage in line with ICH E3

• Drafted assigned sections of a CSR to ICH E3 standard, including a CSR shell and patient safety narratives for serious adverse events, ensuring consistent document structure, full source-data traceability and QC-verified accuracy across data, tables and references

• Produced a complete clinical study protocol and protocol amendment, covering objectives, endpoints and Schedule of Assessments to ICH E6 (GCP) standard, incorporating reviewer feedback across review cycles to bring both documents to final draft stage

• Authored the Schedule of Assessments for a separate clinical study protocol, ensuring procedural consistency and alignment across study documents in line with ICH E6 requirements

• Compiled a Module 2.7.4 clinical safety summary integrating TEAEs, SAEs and AESIs across multiple studies in line with ICH M4E and EMA/MHRA CTD requirements, resolving cross-functional review comments to deliver a submission-ready document

• Developed an Investigator's Brochure safety-update section, synthesising SME input and source data into concise, evidence-based content for investigator audiences

• Applied detailed QC and consistency review across multiple documents, including formatting audits, identifying and resolving discrepancies in data, tables, references and style guide compliance prior to finalization

Therapeutic Areas: Neurology, Pharmacology, Endocrinology

• Copy-edited clinical and health articles for grammar, style consistency and scientific clarity

• Delivered fact-checking, source verification and reference accuracy review to publication standard

• Improved readability and structure of scientific content for clinical and lay audiences

Therapeutic Areas: Oncology, Orphan disease, Cardiology, Neuropsychiatry, Endocrinology

– Authored 200+ individual case safety narratives (spontaneous, clinical trial, literature) in compliance with ICH standards, consistently meeting tight regulatory timelines

– Wrote and implemented Safety Management Plans for 10+ clinical trials, ensuring full alignment of safety reporting obligations across all study stakeholders

– Trained and mentored a PV service provider team of 20+ members on case processing standards, directly reducing error rates in outsourced activities

– Conducted systematic case quality control and literature monitoring across a portfolio of studies, improving signal detection accuracy and regulatory compliance

– Collaborated with cross-functional teams (clinical operations, medical writing, quality assurance) to develop SOPs and activity guidelines