Koteswari Yallamanda (L* visa holder)

+1-408-***-**** ad4l85@r.postjobfree.com Sunnyvale, CA

PERSONAL PROFILE

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 ompany.

Technical SKILLS

●ADR Classification and SAE determination

●Basic Knowledge on Therapeutic areas and diseases

●Drug Classification

●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

●Labeling

●Signal Detection and Causality Assessment

●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).

SOFT SKILLS

●Observation and ability to grasp faster

●Clear and effective communication skills (written and verbal) and Multi-tasking

●Decision making

●Strong attention to detail

●Determination towards work

●Ability to work efficiently in multicultural environments.

●Quality oriented with Attention to details

● Excellent Team player with ability to work in a Team environment

● Manage, Plan and Organize work assignments and work under strict timelines

●Excellent Verbal and Written communication

●Efficient user of Microsoft office tools (Word, Excel, PowerPoint, Visio, Project)

WORK EXPERIENCE

Cognizant technological solutions (Client: Novartis)

Designation: Junior data analyst

Duration: Nov 2020 – Aug 2023

Environment:Argus database (8.1, 8.2.3, 13.0.3, 14.0.2)

•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.

Pellets pharma limited

Designation: Technical trainee

Duration: Jun 2019 – Jun 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.

M Pharmacy thesis

Pellets pharma limited

Oct 2018 – May 2019

●Formulation and Evaluation of Aprepitant 40 % IR pellets.

●Knowledge and formulated Esomeprazole pellets and capsules of different strengths.

EDUCATION

Masters of pharmacy

Bapatla college of pharmacy (Bapatla) affiliated to Jawaharlal nehru technological university

Kakinada,India

2019

Percentage: 80%

Extracurricular Activities: Team Coordinator of SAC (suryodaya society for awakening community)

Elected Captain of SAC

Research Project: Esomeprazole pellets

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