Aneesah Huda

• Provide medical inputs in processing of Individual Case Safety Reports (ICSRs)
• To carrying out the review of Designated Medical Events (DMEs) and to identify events of special interest
• To perform medical review of individual case Safety reports of all case types including literature, non- literature and solicited clinical trial cases
• To perform Analysis of seriousness of events based on medical assessment
• To perform Causality assessment of Individual Case Safety Reports (ICSRs) based on excellent medical knowledge and causality assessment criteria
• Gaining knowledge of Corrective and preventive action (CAPA) and performing root cause analysis
• To perform quality review and checking cases for discrepancies for any errors related to labeling and narrative writing
• Getting accustomed with typical tools used in Pharmacovigilance
• To Interact with client personnel to discuss potential signals and safety issues identified with products
• To prioritize and maintain timelines as per client and Regulatory requirements
• Maintaining consistency of safety assessment
• MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”
• Maintaining good working knowledge of the safety profile of assigned drugs, Reference Safety Information documents, aggregate reporting conventions and guidelines, clients' procedures and international drug safety regulations including

1. ICH guidelines on safety and efficacy

2. FDA guidelines

3. GVP Modules

4. CIOMS

5. New EU PV legislation

6. Awareness about ethical guidelines for human and animal trials

• Streamlined adverse event case processing through the implementation of efficient workflows and procedures.
• Developed strong relationships with key opinion leaders in the field, facilitating open communication on drug safety topics.
• Assisted in the preparation of periodic safety update reports, ensuring timely submission to relevant regulatory authorities.
• Mentored junior staff members in pharmacovigilance best practices, fostering a culture of excellence and continuous learning.

• Managed all Medical Emergencies
• Ward duties & ICU patient management
• Worked in outpatient department.
• Case file reviews & approvals
• Managed Medical Emergencies
• Worked in inpatient and outpatient department
• Monitored patient progress and adjusted treatments accordingly.
• Enhanced patient satisfaction with thorough assessments, diagnoses, and treatment plans.
• Participated in ongoing professional development opportunities to stay current with advances in medicine and enhance clinical skills.
• Assisted senior physicians and surgeons during assessments, examinations and surgical interventions.
• Promoted a culture of safety within the healthcare facility, adhering to strict infection control measures and reporting potential hazards.

• Consultations for chronic cases (Hypertension, Diabetes, Other ailments)
• Minor Surgeries- Clean Lacerated Wound (CLW) suturing, assisting in minor procedures (Surgical and Obstetrics & Gynecology)
• Admirable experience in providing intensive care in emergency department
• Responsible for Documentation of ward rounds with consultant
• Skilled in handling the emergencies and road-side traumas
• Highly dedicated and trained to diagnose, monitor and treat patient who have life threatening illness and injuries
• Taking informed consent from patients for any invasive procedure to be undertaken
• Experienced in handling patients in outpatient department (OPD)
• Experienced in intubating patients.
• Improved patient outcomes and delivery of care through improved clinical quality processes.
• Applied continuous process improvement strategies to enhance case management, programs and clinical management.