AKANSH GOEL

• Led a team of safety associates in processing and reviewing Individual Case Safety Reports (ICSRs).
• Ensured compliance with global regulatory requirements (FDA, EMA, MHRA) and internal SOPs.
• Mentored and trained junior staff on pharmacovigilance processes and regulatory updates.
• Literature Monitoring, including review and validity assessment of abstracts.
• Quality Check of ICSRs/SUSARs, including MedDRA coding review and narrative review to ensure high quality of safety reports in accordance with the client SOPs and regulatory requirements.
• Data analysis along with preparation and update of Investigator’s Brochure and Labels.
• Preparation and review of Safety Management Plan.
• Training the team on AWINSA’s/ Client’s SOPs, conventions, and guidelines.
• Review of Clinical Study Reports and TLFs.
• Generation and execution of Standard Operating Procedures.
• Review and Preparation of Aggregate reports, including Development Safety Update Report.
• Submit the case safety reports to regulatory authorities as per the requirements.
• Submission of SUSAR, IB, and DSUR to the Ethics Committees/Institutional Review Boards, Competent Authorities, and investigational sites.
• Generate and review queries for missing information and inform the Medical/Scientific reviewer to validate queries.
• Generation and review of the Change Control Forms and User Access Management Forms and maintenance of the client-specific CCF and UAM tracker and documentation.
• Ensure compliance with AWINSA’s/ Client’s SOPs, conventions, and guidelines, as applicable for all activities performed.
• Demonstrated expertise in SAE reconciliation between clinical and safety databases.
• Successfully faced multiple client audits with zero critical findings.
• Managed eTMF documentation for pharmacovigilance activities, ensuring timely upload, indexing, and compliance with ICH-GCP and regulatory standards.
• Conducted periodic quality checks and reconciliation of safety-related documents within the eTMF to maintain inspection readiness.
• Collaborated with cross-functional teams to streamline eTMF workflows, improve document traceability, and support audit and inspection preparedness.

• Literature Monitoring including review and validity assessment of abstracts
• Triage, Data Entry and Quality Review of of clinical trial ICSRs including MedDRA coding and narrative writing in AWINSA's pharmacovigilance safety database Argus Safety or client database
• Follow-up Query generation, review and management and interacting with client personnel to resolve issues related to the processing of ICSRs in accordance with clients' policies
• Archive all source documents and correspondence mails relevant to case in individual case folders in the source document archiving tool
• Perform validation of the data for each case and make any corrections as needed
• Proficient in eTMF document collection and upload.
• Preparation and review of Aggregate reports including Developmental Safety Update Report as per the regulatory requirements for different countries
• Generation and review of the Change Control Forms and maintenance of the client specific CCF tracker and documentation
• Generation and review of the User Access Management Forms and maintenance of the client specific UAM tracker and documentation
• Training the team on AWINSA's/Client's SOPs, conventions, and guidelines
• Preparation and review of Reconciliation reports including generation of listing from the safety database and comparing it with the clinical database and drafting the discrepancy log and ensuring its closure
• Submission of SUSAR, IB, and DSUR to the Ethics Committees/ Institutional Review Boards, Competent Authorities, and investigational sites

• Literature Monitoring including review and validity assessment of abstracts
• Triage, Data Entry and Quality Review of of clinical trial ICSRs including MedDRA coding and narrative writing in AWINSA's pharmacovigilance safety database Argus Safety or client database
• Follow-up Query generation, review and management and interacting with client personnel to resolve issues related to the processing of ICSRs in accordance with clients' policies
• Archive all source documents and correspondence mails relevant to case in individual case folders in the source document archiving tool
• Perform validation of the data for each case and make any corrections as needed
• Generation and review of the User Access Management and Change Control Forms and maintenance of the client specific trackers and documentation
• Preparation and review of Reconciliation reports including generation of listing from the safety database and comparing it with the clinical database and drafting the discrepancy log and ensuring its closure

• First Aid treatment, drug dispensing, patient counseling, injections etc