Cooking and baking
Vaishali Jamdhade
Drug Safety Associate II
Nashik
Summary
Logical Drug Safety Associate with background identifying, assessing and preventing adverse effects or medications, vaccines and related pharmaceutical items. Dedicated expert with focus on maintaining drug safety by preparing and reviewing data and reports. Meticulous when authoring professional documents and reviewing scientific literature.
Overview
3
3
years of professional experience
3
3
Languages
Work History
Drug Safety Associate II
Qinecsa (Bioclinica) Solutions Pvt. Ltd.
11.2021 - 08.2022
- Performed quality checked of ICSRs and provided feedback of any observation to the individual who processed the ICSR. In case of any major errors in cases, should been escalated to the appropriate line manager.
- Supported group leader for timely submission of ICSR in ordered to achieve 100% regulatory compliance.
- Processed suspected unexpected serious adverse reaction (SUSAR) cases in clinical studied, strictly compliant to 7- day and 15-day timelines.
- Performed the tasks of maintaining the safety database and perform coding of diseases as well as adverse events according to the project-specific coding conventions.
- Adverse event (AE) coding by MedDRA browser and drug coding by WHO-DD browser, working on argus safety database, coding events, indications and patient history based on MedDRA.
- When needed, support have been given for performing case processing including data entry, drug coding, MedDRA coding, listedness, assessment for expediting, narrative writing of ICSR in accordance with company's controlled documents (e.g., SOPS, WIs, Guide) relevant regulations and guidelines.
- MedDRA coding and narrative writing, processing different cases liked E2B, line listing case).
- Performed other supportive activities as assigned.
- Ensured compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and company's global pharmacovigilance requirements
Junior Data Analyst (JDA)
Cognizant Technology Solutions Pvt. Ltd.
11.2019 - 11.2021
- Performed book-In, triage activities, validation of cases, data entry activities from reported source documents with expedited and non-expedited reporting of adverse reactions with almost 100% quality.
- Evaluated incoming case reports for completeness, accuracy, and consistency before entering them into the global safety database.
- Processed various type of cases including spontaneous, NIS, literature, POP, E2B and special product cases.
- Ensured case processing with internal standards and external regulations within standard timelines as per company and respected authority.
- Experienced in narrative writing with manual and auto generation both methods.
- Oversaw adverse events case reporting and conducted follow-up.
- Evaluated ICSRs for validity and consistency.
- Generated action items in safety database.
- Performed safety case correction, deactivation and rejection activities.
Education
Master of Pharmacy -
Savitri Bai Phule Pune University
Pune 04.2001 -
Bachelor of Pharmacy -
Savitri Bai Phule Pune University
Nashik2017
Skills
Self-Driven
Accomplishments
- Promoted as Quality reviewer based upon performance.
- Appreciation from the Leads for the excellence in processing task.
- Appreciation for being Active member in achieving Team goal (by over productivity and extra time Support)
- Winner of “Sanjivani Avishkar -2016” held at Sanjivani College of Pharmaceutical Education and research, Kopargaon on 31st January 2016.
- Student council member (as ladies representative) of MSGCOPER, Nashik (2014-2016).
Interests
Crafting
Personal Information
- Father's Name: Mr. Jamdhade Kailas Nivrutti
- Spouse's Name: Mr. Wagh Akshay Mukund
- Date of Birth: 04/13/1995
Timeline
Drug Safety Associate II
Qinecsa (Bioclinica) Solutions Pvt. Ltd.
11.2021 - 08.2022
Junior Data Analyst (JDA)
Cognizant Technology Solutions Pvt. Ltd.
11.2019 - 11.2021
Master of Pharmacy -
Savitri Bai Phule Pune University
04.2001 -
Bachelor of Pharmacy -
Savitri Bai Phule Pune University
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