Dr.Diksha Chawla
Brampton,ON
Summary
Dentist and Pharmacovigilance Professional with 4.5 years of experience in capturing and assessing single adverse event reports associated with client products on a worldwide basis on Client's safety database. Strong Knowledge of MedDRA, WHO Drug Dictionary and coding practices. Thorough understanding of adverse event reporting and safety databases. Good Knowledge and understanding of the Standard Operating Procedures and abiding by the guidelines.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Principal Operations Scientist
Complete Pharmacovigilance Solutions
02.2022 - 07.2023
- Literature surveillance: Assessment and review of Literature abstracts and full text articles
- Conducting review and assessment of ICSRs
- Evaluates adverse event reports, assesses regulatory status which is seriousness and relatedness in order to prioritize workload and ensure timely submission
- Case processing: Spontaneous, regulatory, Literature, and Clinical trial cases in 'Clinevo' database (Initial and follow-ups) from source documents like CIOMS, XML, ADR forms, and emails
- Combination products (PV+ MD) cases: spontaneous AE+PQC cases and writing narrative in 'AB Cube- Safety Easy' (Initial and follow-ups)
- Regulatory case processing (EvWeb-R3 and MHRA R2 XMLs)
- Vaccine cases: Clinical case processing + Narrative writing in Argus safety database using pdf from EDC (Medidata)
- Quality review of cases for errors, missing information, and legibility
- Ensures cases are processed per conventions and regulations
- Reviewing appropriate selection of adverse events from source documents, assigning appropriate MedDRA code and reviewing case narratives
- Evaluate causality, seriousness and listedness for all cases
- Ensure the case narrative comprises correct and appropriate safety information
- Acquiring complete knowledge of the product portfolio and safety profiles for the product s across therapeutic areas
- Conduct Quality huddle for team discussing the ongoing trends in error and cascading the latest process updates to the team
- Case Reconciliation of clinical study data between PV & EDC database; TGA DAEN check
- CAPA: Writing Corrective and preventive actions for any deviation in the process
- Preparation of SDEA agreement with multiple Clients
- Preparation of RMPs
- Successfully faced multiple Client audits.
Pharmacovigilance Associate
APCER Life Sciences
10.2021 - 02.2022
- ICSR downloads: ICSR download from EV Web, MHRA (download and send Acknowledgement)
- End to End case processing in Pharmacovigilance database Argus
- Assessed labelling of serious adverse events originating from spontaneous, clinical sources with reference of IB, CCDS and SmPC
- Processed literature cases which included cases from medical journals abstracts, poster presentation, literature summary cases and full narrative articles
- Requested and provided follow-ups on adverse events by preparing, sending out and tracking queries
- As mentor, trained new team members on Safety data processing and project related activities.
Drug Safety Associate
Pharmalex- India
07.2019 - 09.2021
- ICSR downloads: ICSR download from EV Web, MHRA (download and send Acknowledgement)
- End to End case processing in Pharmacovigilance database Argus
- Assessed labelling of serious adverse events originating from spontaneous, clinical sources with reference of IB, CCDS and SmPC
- Processed literature cases which included cases from medical journals abstracts, poster presentation, literature summary cases and full narrative articles
- Requested and provided follow-ups on adverse events by preparing, sending out and tracking queries
- As mentor, trained new team members on Safety data processing and project related activities.
Education
Post Graduate Diploma - Clinical Research and Pharmacovigilance
Institute of Clinical Research -MIER
New Delhi, India01.2019
Bachelor in Dental Surgery - Dentistry
Institute of Dental Sciences, Bareilly, UP
Bareilly, Uttar Pradesh, India01.2017
Skills
- Technical Skills: Pharmacovigilance, ICSR Case Processing, GVP VI, Global literature surveillance, Regulatory timelines, GCP(E6R2) & its Principles, Electronic data capture (EDC), Investigator & Sponsor responsibilities, Protocol, ICF, CRF
- Interpersonal skills: Active listening, Teamwork, Leadership, Patience, Communication skills, Attention to detail, Creative
- PV data safety system Knowledge (Oracle Argus, PVEdge, AB Cube Safety Easy, Clinevo, BPI Pheda), XML R2, search string in PubMed database, Bioinformatics tools (Homology modeling, Docking), SQL query, Microsoft Office (Word, Excel, PowerPoint), Databases like NCBI, PubMed
Languages
English
Full Professional
Certification
Certificate Course in Pharmacovigilance Aggregate Reporting.
Timeline
Principal Operations Scientist
Complete Pharmacovigilance Solutions
02.2022 - 07.2023
Pharmacovigilance Associate
APCER Life Sciences
10.2021 - 02.2022
Drug Safety Associate
Pharmalex- India
07.2019 - 09.2021
Post Graduate Diploma - Clinical Research and Pharmacovigilance
Institute of Clinical Research -MIER
Bachelor in Dental Surgery - Dentistry
Institute of Dental Sciences, Bareilly, UP
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