Nikhitha Pallagutla

Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.

Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.

o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.

o Enters data into safety database.

o Codes events, medical history, concomitant medications, and tests.

o Compiles complete narrative summaries.

o Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.

o Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.

Maintains safety tracking for assigned activities.

Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.

Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.

Manual recoding of un-recoded product and substance terms arises from ICSRs.

Identification and management of duplicate ICSRs.

Activities related to SPOR / IDMP.

Quality review of ICSRs.

Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for postmarketing

programs as appropriate.

Maintains understanding and compliance with SOPs, Work Instructions (Wls), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.

Fosters constructive and professional working relationships with all project team members, internal and external.

Participates in audits as required/appropriate .

Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

• Perform end-to-end case processing and quality check (QC) of ICSRs including Spontaneous, Solicited, and Literature cases.
• Conducted QC review of coding for medical history, adverse events, drugs, indications, procedures, and laboratory tests to ensure compliance with MedDRA, WHO-DD, and Company Product Dictionary.
• Evaluate seriousness, expectedness, and causality at event and case level.
• Prepared and reviewed high-quality, medically accurate safety narratives to meet global regulatory requirements.
• Conduct peer review to ensure case quality, accuracy, and consistency prior to submission.
• Served as Subject Matter Expert (SME) and mentored junior team members to enhance team knowledge and case processing quality.
• Maintain up-to-date knowledge of global pharmacovigilance regulations and reporting requirements.
• Triaged ICSRs for completeness, accuracy, legibility, and validity.
• Performed data entry of case reports into safety databases.
• Evaluated seriousness, causality, and expectedness of cases.
• Coded adverse events, medical history, and concomitant medications.
• Processed spontaneous, solicited, literature, MLM, MHRA, and health authority cases.
• Conducted follow-ups and query resolution.
• Worked on Argus and ARISg databases.
• Collaborated with cross-functional teams.
• Prioritized deliverables during critical timelines.

• Prioritized and processed Individual Case Safety Reports (ICSRs) based on seriousness criteria and global regulatory timelines.
• Managed ICSRs from diverse sources including health authorities, literature, MLM, Adis databases, and full-text scientific articles to ensure comprehensive safety reporting.
• Performed case receipt, validity checks, duplicate searches, and case registration in respective safety databases.
• Conducted accurate data entry of adverse event reports from source documents, including:
• Developed clear, medically accurate safety narratives adhering to SOPs and client guidelines, enhancing communication of safety information.
• Executed literature screening and article review to pinpoint reportable safety information, supporting regulatory compliance and risk assessment.
• Conducted literature screening and article review to identify reportable safety information.
• Gained hands-on experience with Oracle Argus Safety (initial case entry, duplicate check, complete case processing) and ARISg databases.
• Applied strong knowledge of case triage, narrative writing, listedness/labeling assessment, and causality determination.