Maha Abdelmonem Kandil

Regulatory Affairs Specialist and Pharmacovigilance OfficerFull Time

• Job Details:• Responsible for recording and reporting any received complaints from healthcare professionals and consumers according to the SOPs and following up with the manufacturer. • Informing the Medical Device Safety Department in the Egyptian Pharmaceutical Vigilance Center about any complaint according to the guidelines. • Prepare and submit technical files necessary to obtain product approvals/release according to CAPA guidelines. • Prepare and submit technical files necessary to obtain registration license according to CAPA guidelines.

Medical TranscriptionistFull Time

• Job Details:• Transcribe all patient data into electronic health records system. • Create a report with the available results for physicians to approve. • Format, identify inconsistencies, errors, and missing information within a report that could compromise patient care. • Follow patient confidentiality guidelines and legal documentation requirements.

Clinical Research Associate and Pharmacovigilance OfficerFull Time

• Job Details:• Involved in monitoring of an international registry study with a drug eluting cardiac stent at six centers in Egypt. • Involved in start-up and management of one study site in Greece including study specific training of the local monitor. • Attended a study specific training course related to the study protocol, study procedures, completion and monitoring of eCRF entries, monitoring procedures and forms, as well as an introduction to EN ISO 14155:2011, Declaration of Helsinki, ICH-GCP. • Responsible for recording and reporting any received complaints from healthcare professionals and consumers according to the SOPs and following up with the manufacturer. • Informing the Medical Device Safety Department in the Egyptian Pharmaceutical Vigilance Center about any complaint according to the guidelines.