Syeda Ayesha Sadaf

Case Processing:

• Trained in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies, and solicited programs) with Licensed Partner, European Medicines Agency (EMA), and Health Authority cases, which includes:
• Triage of ICSRs to determine whether they qualify for expedited reporting or not, and the timelines within which they need to be submitted to the regulatory authorities.
• Registration of ICSRs into the safety database.
• Conducting duplicate searches prior to registration and identifying potential duplicates.
• Managing duplicate couples/cases appropriately.
• Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents (such as Summary of Product Characteristics (SPC), Core Data Sheet (CDS), Investigator's Brochure (IB), etc.), writing case summaries, assessing causalities, and writing company comments.
• Trained in MedDRA coding in accordance with 'MedDRA Term Selection: Points to Consider' and WHO-Drug dictionaries.
• Trained in maintaining a good working knowledge of the adverse event (AE) safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, client procedures, and international drug safety regulations including:
• International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines on safety and efficacy.
• Food and Drug Administration (FDA) guidelines.
• Council for International Organizations of Medical Sciences (CIOMS).
• New European Pharmacovigilance (EU PV) legislation.
• Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
• Trained in handling the Enterprise Resource Planning (ERP) tool.
• Processing adverse event (AE) and endpoint information.
• Ensuring database entries are accurate and compliant.
• Writing narratives, coding AEs, and managing products in line with project timelines.

Query Management:

• Trained in interacting with client personnel to resolve issues related to the processing of ICSRs in accordance with clients' policies.
• Trained in responding to clients/customers in a timely manner.

Technical Skills:

• Working on Oracle- ARGUS safety database.
• Experienced in working with basic tools such as MS Word, MS Excel, and MS PowerPoint.
• Training and mentoring new team members and providing feedback on challenges and successes.
• Performing Quality Control (QC) of cases for accuracy of data captured in the safety database.
• Solving intra-team queries related to case analysis, corrections, and coding conventions.

• Generated or completed report requests, followed up on open requests, and ensured all information is received, distributed, and accurate.
• Efficiently, effectively, and accurately documented request progress in case management system.
• Ensured all policies and procedures are followed appropriately, with emphasis on strict adherence to HIPAA guidelines.
• Proved successful working within tight deadlines and a fast-paced atmosphere. Worked flexible hours, night, weekend, and holiday shifts.
• Resolved problems, improved operations, and maintained effective communication and a good relationship with all clients.
• Performed at a high level of quality to eliminate the potential for incorrect transfer of Patient Health Information.