Summary
Overview
Work History
Education
Skills
Timeline
Generic

Koteswari Yallamanda L2 Visa Holder

Sunnyvale,CA

Summary

Pharmacovigilance professional with a warm and friendly demeanor always! Skilled at Team management, ICSR / Case processing and PR/QC activities. Currently seeking a challenging opportunity to invest my technical and academic skills to grow with the passionate organization that utilizes my full potential and while doing so, I want to play my role with the everlasting efforts to improve the quality of life of the patient. To perform all the activities as per management requirement and to grow along with company.

Overview

4
4
years of professional experience

Work History

Junior data analyst

Cognizant technological solutions (Client: Novartis)
11.2020 - 08.2023
  • Therapeutic areas included: Immunology, Dermatology, Oncology, Ophthalmology and Cardiology
  • Triage, Book-in, Full data entry, QC of safety cases
  • Case management activities including in literature, solicited (POP, NIS, and MAP), Spontaneous cases, HA, EVHUMAN, Discharge summary cases and license partner cases received via E2B, CIOMS and MedWatch forms
  • Clear understanding on Device case processing and combination products
  • As a Peer reviewer: Confirms validity, evaluates event Seriousness, event term selection and MedDRA Coding, labelling assessment, Narrative writing, and review
  • Peer review of the cases and evaluates accuracy, consistency, and completeness in the safety database against the source document
  • This includes, but is not limited to, checking the consistency of narrative and other data fields, and ensuring the main reason for any delay is entered in the routing comment as appropriate
  • Case triage activity including case validity check by analyzing source document and performing duplicate search in safety database
  • To perform medical coding, product coding using WHO, MedDRA dictionaries
  • Narrative writing/ I-narrative summarizing case information for all safety cases
  • Perform case corrections, deactivation, case rejection and NTBD (not to be database)
  • Reconciliation of Safety data communications and follow up on discrepancies
  • Drafting errors across site gathering RCAs, implementing and closing CAPA on time, monitoring Turn Around Time (TAT) for ICSRs submission, and handling the triage of reports for daily workflow management
  • Ad hoc activity EV Triage
  • Involving in active discussions in team meetings with respect to change/updates in process
  • Assists in the training and mentorship of other case processing associates as necessary
  • Taking up additional activities apart from case processing
  • Build a positive, collaborative team environment with project team members
  • Collaborated with cross-functional teams to develop data-driven insights and recommendations for business improvements.

Technical trainee

Pellets pharma limited
06.2019 - 06.2020
  • Equipment worked: FBD (5kg platina, 25kg FBC), Tablet punching, dyno mill, capsule filling machine
  • Phase 0 and I clinical trial
  • Pharmaceutical Machinery handling
  • Followed GCP, GDP while Development, manufacturing and evaluation of Esomeprazole IR pellets and capsules
  • Formulation/Evaluation of pellets and capsules
  • Hands-on fluid bed coater(5kg platina, 25kg FBC) and nano-milling through a dyno mill
  • Hands-on compression machine and capsule filling machine
  • Compilation of data given by ARD of particular project
  • UV-Visible spectrophotometer
  • Pelletization technology
  • Using different types of equipment to reduce particle size of drugs and for the formation of pellets and capsules
  • Developed problem-solving skills by troubleshooting technical issues for failure of product
  • Enhanced software proficiency by completing hands-on technical training and collaborating with experienced colleagues
  • Conducted thorough research on emerging technologies to stay current with industry trends and advancements
  • Collaborated with cross-functional teams on various projects, enhancing teamwork skills and adapting to different work styles.

Education

Pharmaceutical Sciences

Bapatla College of Pharmacy (Bapatla) Affiliated To Jawaharlal Nehru Technological University
Kakinada, India
10.2019

Skills

  • ADR Classification, Therapeutic areas and diseases and SAE determination
  • Case processing experience
  • Clinical trial knowledge
  • Project management experience
  • Quality Assurance Practices
  • Pharmacovigilance expertise
  • Drug safety regulations
  • Adverse event reporting
  • Technical writing proficiency
  • Signal detection abilities
  • Strong Communication Skills
  • Data analyzation
  • Data Collection
  • Safety Management
  • Drug development
  • Root Cause Analysis
  • Expert in [Oracle ARGUS]
  • Proficient in ARISg
  • Drug Labeling Review
  • Pharmacodynamics Understanding
  • Medical Writing
  • Pharmacokinetics Knowledge
  • Patient Safety Assessment
  • Post-marketing surveillance
  • Case Processing
  • Drug Safety Monitoring
  • ICH Guidelines
  • Risk management planning
  • Pharmacovigilance Regulations
  • Knowledge on Clinical trials from Phase 0 - IV, human anatomy, GDP, GCP environment, product life cycle, Drug action on human body
  • Expert in Phase V clinical trials ARGUS safety database handing
  • Interpretation of complex medical data from different types of sources
  • MedDRA coding, WHODD
  • CDS, USPI, SOP’s
  • Sound knowledge on PSUR, PBRER, PADER and Canadian aggregate reports
  • Handling of XML files, EVWEB and PUBMED
  • Maintain knowledge of global health authority regulations and requirement
  • Drug Safety regulations (ICH-GCP, GxP, GVP modules with new Pharmacovigilance legislation, 21 CFR Part 11, FDA,GVP, EU Annex 11, Health Canada and GAMP 5 Standards)
  • Manage, Plan and Organize work assignments and work under strict timelines
  • Efficient user of Microsoft office tools (Word, Excel, PowerPoint, Visio, Project)

Timeline

Junior data analyst

Cognizant technological solutions (Client: Novartis)
11.2020 - 08.2023

Technical trainee

Pellets pharma limited
06.2019 - 06.2020

Pharmaceutical Sciences

Bapatla College of Pharmacy (Bapatla) Affiliated To Jawaharlal Nehru Technological University

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Koteswari Yallamanda L2 Visa Holder