DAWALJI VAISHNAVI
Bridgeport,CT
Summary
To be associated with a progressive organization which will provide a dynamic work sphere to extract by inherent skills has a profession and develop aptitude for further organization and also attain career targets in the progress. SYNOPSIS Personal appeal in communication skills, quick learning, condition analysis, handling the solution. To work in a responsible position of a highly competitive, professional work culture to enrich skills and to explore knowledge by achieving individual and organization goals. Sincere and hardworking Proactive attitude and quick learner Ability to work in any kind of atmosphere Punctual and Desired to learn Implementation in time CORE.
Overview
1
1
year of professional experience
1
1
Certificate
Work History
Product Safety Surveillance Report (PSSR)
Clario
Mysore(India)
03.2022 - 08.2022
- I worked as a case reviewer. Analyze the prioritization and data entry of the case. Inspecting the cases done by the data entry team, checking the cases according to the standard operating procedures.
- Inspecting the cases according to the BLA OR EUA license, determining the listedness according to the event and inspecting the seriousness criteria of the cases.
- Generating the narrative and modifying it according to the raw narrative of the cases.
- Alert the medical safety physicians to the potential safety issues and assist the medical safety physicians in monitoring the safety profile of the product as appropriate.
- Raising the DSS notification and raising the query to the query management team if there is any discrepancy in the Safety Report.
- participate in cross-functional teams on safety matters, especially projects relating to investigational and marketed drugs and attend the CAPA sessions.
- Conducting the knowledge sharing sessions about different types of case scenarios within the team.
- performed the necessary follow-up for missing any information or any other clinical information added. and checking the ICSR and mandatory validation. accessing and determining if it is significant or non-significant.
Drug Safety Associate
Clario
Mysore (India), India
04.2021 - 03.2022
- Case Book In, Case Processing, Review)
- Operational Responsibility -
- Keeping work log and query log updated and completing requisite trackers
- Performing Triaging, duplicate search, processing case and then forwarding case appropriately for primary review (Working in Argus database)
- Processing of various types of cases such as Spontaneous, Post market research and etc
- Validity assessment for all cases and determining seriousness of events
- Coding of suspect products using, concomitant products using CDD or WHO dictionaries
- Knowledge of WHO/MedDRA dictionaries
- Generating follow up letters if required i.e., determining, and performing appropriate case follow-up, generating, and requesting due diligence letter
- Keeping work log and query log updated and completing requisite trackers
- Coordinating and conducting knowledge sharing sessions for different type of case scenarios in team
Education
Master of Science - Health Sciences
Sacred Heart University
Fairfield, CT12.2023
B.Pharmacy -
Vishnu Institute of Pharmaceutical Education And Research
INDIA11.2020
Skills
- Pharmacovigilance, R3E2b, R2E2b, ADR, ADE, ICH guidelines, GCP guidelines, Drug discovery, Clinical research clinical phase trials, Drugs and its qualifications, good clinical practice, minimum criteria for valid case, MEDRA,Hierarchy of MEDRA,Volume 9A,ICSR,elements of ICSR, Regulatory bodies, signal Detection,Risk Management, pre marketing survival lance, post marketing surveillance, causality, drug abuse drug missuses
- Good communication skills, positive attitude, hardworking, team player, self confidence
- Imitative problem solving Quick learner, decision making, ability to follow instructions
- MS Office (Word, PowerPoint, Excel)
Certification
- Certified , In Pharmacovigilance Management system and terminologies_Uppsala Monitoring Center
- Certified , In Pharmacovigilance adverse event monitoring_Uppsala Monitoring Center
Timeline
Product Safety Surveillance Report (PSSR)
Clario
03.2022 - 08.2022
Drug Safety Associate
Clario
04.2021 - 03.2022
Master of Science - Health Sciences
Sacred Heart University
B.Pharmacy -
Vishnu Institute of Pharmaceutical Education And Research
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