JISNA HAMEED

I am currently managing Individual Case Safety Reports (ICSR) of Global

Pharmacovigilance department of the client involving duties of:

• Medically confirming accurate coding of reported term against MedDRA.

• Assessing Company Causality and providing Company rationale/remark for the same.

• Confirming the labelling assessment against the Reference Safety Information

(RSI)/other applicable labels.

• Ensuring medically cohesive, consistent case narrative.

• Confirming the correct identification of Suspected Unexpected Serious Adverse

Reactions (SUSARs).

• Writing Analysis of Similar Events (AoSE) for the cases requiring IND

submission.

• Requesting follow-up information and initiating appropriate queries for missing

information

• Identifying potential signals arising from the ICSRs and communicating with

respective stake holders.

• Representing Medical Reviewers during Audits and Inspections.

• Responsible for end-to-end safety of the products in the supply chain which

includes diverse portfolio (Rheumatology, Haematology, neurology, respiratory

medicines, and oncology).

• Actively collaborating with internal & external stakeholders for safety related

activities, tracking safety surveillance of the molecule in collaboration with safety

lead.

• Assessed and analyzed detailed medical charts to evaluate patient conditions.
• Reviewed full chart histories to create comprehensive medical summaries.
• Classified medical conditions as 'findings' or 'no findings', providing clear rationales to support clinical decisions.
• Ensured accuracy and compliance with clinical and organizational guidelines, enhancing quality of patient care during review processes.

• Ensured high-quality documentation for patient care within US healthcare system.
• Reviewed patient medical records, ensuring accuracy and completeness for affiliated entities.
• Identified documentation gaps, improving patient care and streamlining processes.
• Collaborated with healthcare providers and administrative staff to provide coordinated patient care.