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. • Participate in and/or leads departmental initiatives to increase efficiencies and optimize processes. • Assist in the tracking and measuring of program/project and team progress through collection of cycle time metrics and other key performance indicators (KPIs). Propose solutions to issues that may arise and strategies to improve metrics/cycle times. • Escalate questions, issues, and potential risks to line manager, or project specific Manager Oversight. • Participate in internal and client audits/inspections. • Maintains understanding and compliance with SOPs, WIs, global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, study/program plans and the drug development process. • Responsible for drafting CAPA to document major/critical non-compliance as applicable.• Oversight of minor non-compliance issues and to ensure they are tracked within the company’s non-compliance trackers/tools as per processes.• Mentor and train new project team members.• Work along with the safety lead to document case status and KPIs within the MESR’s (Monthly Executive Summary Reports) provided for client review.

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 reporting requirements based upon case data, product information, and ICH, FDA, and country specific guidelines and regulations. • 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. • Reconciled safety data with applicable sources as outlined in the Safety Management Plan including identifying and acting on discrepancies and completing required documentation. • Participated in internal/client audit preparation activities.• Participated in client and project team meetings, as applicable. Prepared safety information/tables and/or reports for clients. • Provided operational and technical guidance and direction to colleagues. • Serves as a Safety Lead for medium to large scale, global, complex studies for multiple clients. • Oversight of Eudravigilance regulatory submissions and distribution of Investigator notifications within regulatory timelines. • Was responsible for drafting the Safety Management Plan independently. • Contributed to the development of internal processes and trained new low-level personnel.• Reviewed literature abstracts and full-text articles for reportable safety events.

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 reports.Query management when applicable.

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 Safety Monitoring Plans (SMP) and successfully engaged in study-start up activities.Assisted with drafting the periodic reports (Development Safety Update Report (DSUR)).Escalated queries and followed-up with sites for successful case closure (Query management via Inform EDC).SAE reconciliation activities.Filing, quality control and management of documents in the electronic Trial Master File (TMF).Drug safety and project specific training to members across global teams and new personnel.Assisted with drafting Standard Operating procedures (SOPs) and other guidelines for various aspects within case-processing.Was responsible for reviewing literature abstracts and full-text articles for reportable safety events.Was responsible for providing support for both internal and sponsor audits.Post-marketing: Preliminary triage and routing records within Clintrack Safety and Pharmacovigilance (CSPV).Performed data entry within Argus and prepared case narratives for both Initial/Follow-up serious and non-serious cases. Performed peer quality control (QC) reviews, and was responsible for training new safety personnel.Performed ICSR submissions for both EMA and FDA.Assisted with drafting the Periodic Safety Update Reports (PSUR) and Periodic Benefit-Risk Evaluation Reports (PBRER). Was responsible for electronic tracking and reconciliation of source information (spontaneous or literature).Was responsible for coordinating the basic safety surveillance activities (e.g. non-serious case listings, compliance and metric reports) including successful communication with the Sponsor as applicable.

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 self-knowledge and empowerment. • 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.• Thoughtfully participate in team meetings and share knowledge related to research findings, scientific writing trends, and learning opportunities.• Organizing and scheduling scientific webinars and actively publishing them online.• Create presentations applicable to both scientists and executives.• Sending out newsletters and email notifications using Active campaign.• Providing Customer support via e-mail and live chat for Self decode, a genome analysis web portal.

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 timelines.Drafting Investigator Safety Notification Letters (SNLs) for SUSARs.Providing drug safety and project specific training.Contact study sites for follow-up information on clinical SAE cases.Request and generate follow-up using appropriate communication methods (e.g. Email, telephone, letter).Worked with the team to identify quality improvement initiatives, implement improvement plans, and monitor safety information.Engage with patients and conduct sessions to educate them on drug safety and the use of spontaneous reporting of adverse events.Collect information and create content on different modes of reporting adverse events (face-to-face reporting, questionnaires etc).Conduct in-depth interviews with physicians and health-care professionals.

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 equipment (like HPLC) for the collection of protein/antibody quality data.Mammalian cell culture and maintenance and transfection including: JURKAT Molecular biology techniques including DNA cloning, vector design, plasmid preparation/purification.Diligent in record keeping in a GLP compliant manner and publication in peer reviewed journals.Prepare written protocols, reports and SOPs.Writing up results of research and contributing to publishing results in high-quality peer reviewed academic literature.Supervise new research interns.http://www.sudershanbio.com/http://incozen.com/

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+