CURRICULUM VITAE

Vasavi. B PharmD

Email. adx55a@r.postjobfree.com

Mobile No: 289-***-****

Personal profile

* ***** * ****** ** work experience in Pharmacovigilance in ICSR case management activities as a proactive, adaptable, and conscientious Drug Safety Professional, having the ability to reach targeted goals and have established the reputation as a dependable and accountable employee.

Skilled in possessing excellent analytical and appraisal skills, contributed towards delivering effective communication deals to build a trusted self-brand and position the organization required objectives. Objective:

Aiming to be associated with a progressive organization that gives me the scope and apply my knowledge and skills to involve as part of a team that dynamically works towards the growth of the organization. Educational qualifications:

Qualification

Institution Name University Marks Period

Doctor of Pharmacy

Sri Padmavathi School of Pharmacy,

Tirupati.

82%

2013-19

Intermediate Sri Chaitanya Jr college, Vijayawada. 93.6% 2012-13 SSC Oxford English Medium School 77% 2011

Work experience:

Current Employment

Accenture Pvt Ltd Bengaluru

• Designation: Drug Safety associate L-II Pharmacovigilance (From Jul-2021 to Jul- 2023). Previous Employment

• Previous Organization: Bioclinica Safety and Regulatory Solutions (Synowledge, India Pvt. Ltd), Mysore.

• Department: Pharmacovigilance.

• Designation: Drug Safety Associate (L-1) (From May -2019 to Jun- 2021). RESPONSIBILITIES: Triage

• Responsible for case intake and sending acknowledgement mails.

• Process and prioritize current incoming records in order to meet timelines.

• Duplicate check and registration of all types of case reports (spontaneous, clinical study (PSP), Legal cases, literature, clinical trial cases, pregnancy and child fetus cases and E2B cases).

• Following up with sites with queries and follow up on reconciliation discrepancies.

• Action on case closure and deletion of cases.

RESPONSIBILITIES: Quality Reviewer

• Processed and reviewed high quality expedited and non-expedited, serious and non- serious and post marketing adverse event reports in the ARISg safety database in accordance with the

• client’s data entry conventions

• Quality Review and evaluate AE case information to determine required action based on a following internal policies and procedures

• Assessed expectedness/listedness for all the AEs with respect to suspect drugs against medication guides, Core Data Sheets

(CDS), Investigative Brochures (IB) and United States

• Package Inserts (USPIs)

Review data entered in safety database for completeness and accuracy with reference to Source

• Documents as per applicable SOPs, work instructions and client guidelines.

• Sending queries to the affiliates and SAE responsible persons for the correct information if there is any discrepancy found in the SAE forms.

• To review the coding selected according to the appropriate dictionary.

• To review the medically relevant safety narrative of cases and check the completeness and accuracy of the data entered in the various fields.

RESPONSIBILITIES: Data Entry

• Data review on Company validated database (ARISg)

• Review of safety information from clinical trials and post marketed products

• Handled spontaneous, clinical study (PSP), Legal cases, pregnancy and child foetus cases and E2B cases (Serious and Non- Serious) from health care professionals, patient, business partner and regulatory bodies.

• Responsible for data entry of individual case safety reports (ICSR) into the safety database. • Full data entry including medical coding and Expert in writing narratives for ICSRs.

• Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO- DD). Accountable for performing accurate data capture for individual case safety reports.

• Accountable for performing the appropriate assessments (including the assessment of seriousness, labeling and company causality for each adverse event) adhering to SOPs/other controlled documents and regulatory requirements. Other responsibilities:

• Hands on experience of global drug safety database ARISg 7.4, AGXchange.

• Supervise and mentor new recruits in Triage activity and Resolving their queries.

• Taking up quick huddles to discuss and explain updates within the process and conventions.

• Monitoring of the workflow for assigned studies/programs to ensure all deadlines are met.

• Identifying and resolving issues and conflicts within the team

• Literature case processing

Adhoc Activities

• Maintaining missing batch number activities for all serious cases

• Attaching event PT related task and correspondence activities

• Invalid case processing

Technical Skills:

• Knowledge about ARISG safety database. Personality traits

• Conducting team meetingd/huddles

• Involved in case finalization

• Strong decision-making skills.

• Ability to multitask.

• Preparing and conducting PowerPoint sessions to the team on client updates Involved in case allocation, case prioritization and team data preparation Organizing fun activities.

• High attention to detail and accuracy. Able to react quickly and effectively when dealing with challenging situations. Ability to prioritize own work in response to deadlines.

• Familiar with MS Office tools/database

Declaration:

The information given above is as submitted by me to the best of my knowledge. Strengths:

• Ability to represent the work in a creative manner in any format.

• Quick learner and a good performer. Self-motivated.

• Skilled in technical and general communication both in writing and verbally.

• Ability to give the best results in pressure situations. DECLARATION

I hereby declare that all the above-mentioned information is correct to the best of my knowledge. Place: (B.Vaasavi)

Date:

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