Archana Buddala Email & Phone Number

• Work independently to oversee day to day Safety and Pharmacovigilance (SPVG) activities on assigned projects/programs and working with the team to resolve any issues.
• Exercise independent judgement to troubleshoot and resolve project issues and to identify areas for improvement.
• Oversight of the ICSR workflow for incoming ICSRs and ensuring they are worked on as per the timelines within the SMP.
• Develop innovative solutions to meet unique, client-specific requirements.
• Support management/lead in reviewing and presenting prepared information at project or departmental review meetings.
• Develop training materials, conducts training presentations and on-the-job-training for appropriate departmental teams.

United Kingdom

• Reviewed and analyzed safety report information for completeness, accuracy and regulatory reportability requirements.
• Evaluated safety case data with an emphasis on medical presentation (may conduct discussions regarding specific patient case data with health care practitioners and Sponsors), contributed to determination of regulatory.
• Responsible for sending out triage notifications to clients, performing data entry within Argus, drafting narratives and responsible for peer quality review of ICSRs.
• Identified missing/discrepant data (medical and documentation issues), and addressed queries with site personnel, evaluated query responses, and closed out resolved queries when complete.
• Escalated questions, issues, and potential risks to line manager, safety Lead, or project specific Manager Oversight.
• Contributed to configuration specifications of the safety database, including updates.

Remote

Post-market Legal case processing (HIV drugs):Tracking of received ICSRs.Entry of ICSRs into client safety database.Generate concise, accurate and well-written case narratives.Performs consistent coding of diseases, adverse events, and medications according to the project-specific coding conventions in the Safety database.Peer QC sign-off of AE.

Stirling

Case processing which involved: Preliminary triage of safety information. Data entry (Argus), writing patient narratives for both initial/FU expedited and non-expedited cases.Peer quality control of ICSR reports.Was responsible for submission of regulatory reports (MW/CIOMS).Drafted & QC'd Investigator Safety Notification Letters (SNLs) for SUSARs.Drafted.

Remote

• Conduct research, write and edit web content about a wide range of biomedical research and public health topics. At SelfHacked our goal was to provide comprehensive and accurate information to the public for.
• Survey and select journals for potential content.
• Published over 200 scientific articles online which are very informative, attractive and easy to understand.
• Formatting, editing and managing the ‘’Keyword’’ and ‘’SEO’’ on WordPress.
• Contribute to social media using Buffer (publishing posts on Facebook, Twitter, and Instagram) and video communication projects.
• Follow established editorial voice, including managing journal citations using Mendeley or other software.

Vijayawada Area, India

Electronic documentation and quality control of drug safety information and study narratives for MedWatch (FDA 3500A) and CIOMS forms.Data entry & QC of safety database (Argus), and patient narratives.Generating regulatory reports (MW/CIOMS) from the safety database and submitting reports to the sponsor designee(s) or FDA as appropriate within required.

India

Biotechnological research on protein expression studies in E. Coli and Pichia pastoris.Primary protein identification using protein assays i. e. Biorad assayProtein isolation and characterization using: SDS-PAGE, Native-PAGE, Western BlotProtein purification with FPLC including affinity, ion-exchange chromatography.Utilization of additional analytics.

Hyderabad Area, India

Academic researcher at the International Crops research Institute for the Semi-arid Tropics (ICRISAT).

Master'S Degree, Biotechnology, A+

Bachelor’S Degree, Biotechnology, A+