Amrutha Basina

About Amrutha Basina

Review and evaluate AE case information to determine required action based on and following internal policies and procedures.* Review each auto coded MedDRA term and World Health Organization (WHO) Drug Dictionary terms to ensure accuracy and confirm coding status is resolved. Review the manual coding of adverse events, disease terms, medication, indications, laboratory tests and non-Baxter products performed by Data Entry associate in Centralized coding and WHO Drug Dictionary coding software (PSS coding system).* Confirm the correct suspect drug was selected and correct the suspect drug entry if chosen incorrectly by the LPO. Notifies the LPO of the change as applicable.* Review the adverse events and assess the seriousness as per IME list.* Complete the Reporter Causality assessment at the event level and overall case level.* Confirm Dechallenge and Rechallenge information.* Assess Reference Safety Information (RSI) and U.S. Package Insert (USPI) for expectedness/listedness, as applicable.* Perform self-quality check to ensure all data fields and narrative are correctly populated.* Completes the Quality Review activity, where all the serious cases will advance to Medical Review activity and all non-serious cases will bypass *Medical Review and advance directly to the Distribution activity, except for a subset of non-serious cases, defined in the workflow.* Performing Data Entry of post-marketed Serious and/or non-serious individual case safety reports ensuring compliance with Client standard operating procedures and Work Instructions* Identify and select the cases from workflow, determining appropriate prioritization criteria and submission dates.* Responsible for coding all medical history, events, drugs /procedures/indications, and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD).* Responsible for writing medically relevant Safety narratives of cases and checking the completeness and accuracy of the data entered in the various fields.* Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into adverse event database, review of entered cases for quality.* Quality Check, Distribution and Submission of ICSR’s as per applicable SOPs.* Determining and assessing ICSR reportability to various regulatory authorities based on appropriate regulatory requirements and distributing the reports.

Experience

1. Senior Drug Safety Specialist

   OrciMed Life Sciences Private Limited

   Oct 2025 — Present · Hyderabad, IN

Education

• Bhashyam high school

  Bachelor of Pharmacy - BPharm, Pharmacy, Pharmaceutical Sciences, and Administration

• Jawaharlal Nehru Technological University, Kakinada

  Bachelor of Pharmacy - BPharm, Pharmacy

• Jawaharlal Nehru Technological University, Kakinada

  M pharmacy , Pharmaceutical analysis