Dr. Daniel Abishai Gunasekaran

• Prioritize the medical assessment review in accordance with the regulatory timeline.
• Confirm that the information in the Global Safety Database is accurate and consistent with the Source Documents for applicable ICSRs.
• Assess and confirm the seriousness of the case in accordance with regulatory guidelines.
• Reviews medical content and quality of the case procedures.
• Ensures that all events from the source documents are accurately coded per MedDRA coding guidelines.
• Assess expectedness and listedness of adverse events: assessment of core listedness, expectedness against IB, EU SmPC, US package insert and Canadian monograph or other local labels as applicable for the ICSR.
• Assess company causality of adverse events in all solicited reports.
• Provide feedback for the case creation and data entry leads about the quality of data entry in ICSR cases.
• Offline peer line listing review of agreed sample of Cases for assessment of quality of narrative, E2B sender's comment and medical query completeness as per the agreed schedule.

Training and mentoring:

• A client-certified trainer to coach and train the medical review team and associates as per client requirements.
• Training in internal and external processes, and company policies and procedures, to maintain compliance.
• Coach the team and act as a guide on case discussions and assessments on case creation, literature assessment, ICSR, second triage, and medical device cases.

• Dynamic, live medical scribe with a talent for real-time patient encounter documentation and EHR management.
• Proficient in medical terminology, adept at supporting healthcare providers, and ensuring precise record-keeping.
• Strong communicator with a focus on maintaining patient confidentiality, and facilitating seamless information flow in busy clinical settings.
• Exceptional attention to detail, time management skills, and a commitment to enhancing the efficiency of healthcare delivery.

• Completed clerkship at Fatima University Medical Center and affiliated hospitals for 12 months.
• Performed clinical procedures such as IV Insertion, NGT insertion, Foley catheter insertion, Blood extraction, cardiopulmonary resuscitation, wound suturing, wound cleaning and Digital rectal Examination.
• Developed patient care plans, including medication management and health promotion strategies.
• Provided direct patient care under the supervision of a physician or nurse practitioner.
• Gathered detailed medical histories from patients.
• Conducted physical examinations on assigned patients.
• Participated in interdisciplinary team meetings to discuss patient care plans.
• Educated patients on lifestyle modifications to improve their overall health.
• Observed surgeries and other medical procedures to gain knowledge of specific conditions.
• Assisted and performed in NSD and CS.