Omaya Farah Ragguem

• Case Processing Quality Check:

Review adverse event reports and ensure they are processed accurately and completely.
Verify data entry, coding, and narrative content for consistency and correctness.
Ensure that all necessary follow-up information is obtained and documented.

• Translation:

Translating source documents from French to English

• Compliance and Regulatory Adherence:

Ensure that case processing complies with global regulatory requirements and company SOPs.
Maintain up-to-date knowledge of pharmacovigilance regulations and guidelines.

• Documentation and Reporting:

Prepare quality check reports and summaries.
Document findings and track corrective actions to closure.
Maintain comprehensive records of quality checks and audits.

• Process Improvement:

Identify areas for process improvement and participate in the development and implementation of solutions.
Provide feedback and recommendations to the pharmacovigilance team to enhance quality and efficiency.

• Training and Mentorship:

Assist in training new team members on quality check procedures and pharmacovigilance processes.
Act as a resource for team members on quality-related issues.

• Receive, document, and process adverse event reports from various sources (healthcare providers, patients, literature, etc.).
• Perform case assessments, including causality assessment and seriousness determination.
• Ensure timely submission of adverse event reports to regulatory authorities as per local and global regulations.
• Processed more than 3000 ICSRs includes spontaneous, patient support programs, market research programs and non-interventional studies.
• Handled quality review and performed quality check of ICSR handled by other case processors for accuracy and completeness
• Served as a subject matter expert during inspections, business partner audits and quality investigation.

• Triage and Prioritize cases
• Full data entry of all relevant information from the source data
• Manual coding of all medical terms (that did not auto-encode), including adverse events, medical history, concomitant medications, and laboratory values.

• Contributed to a positive team environment by collaborating with fellow interns on group projects and presentations.
• Sorted and organized files, spreadsheets, and reports.

• Plasma Digoxin concentration analysis, Serum ACE activity, CSF spectroscopy (xanthochromia)

• Blood culture & sensitivity, Chlamydia testing, Stool routine & examination, Antibiotic assays