Preethi Bala
Toronto,ON
Summary
Experienced with drug safety monitoring and regulatory compliance. Utilizes strong analytical skills to assess adverse events and ensure accurate reporting. Track record of effective collaboration and communication within cross-functional teams. Strong background in collecting and analyzing quality measures and making recommendations for process and quality improvements.
Overview
4
4
years of professional experience
Work History
Pharmacovigilance associate I
TEVA PHARMACEUTICALS
09.2021 - 02.2022
- Supplied quality control data necessary for regulatory submissions.
- Supported global pharmacovigilance activities by liaising with international colleagues on common case processing practices, fostering a unified approach to drug safety monitoring.
- Participated in internal assessments and audits as required
- Identified quality problems and recommended solutions
- Responsible for coding all adverse events, medical history, concurrent conditions, concomitant medications, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (For e.g MedDRA, Company Product Dictionary, WHO-DD).
Drug safety associate
ICON CLINICAL RESEARCH ORGANIZATION
12.2020 - 09.2021
- Maintaining a project-specific mailbox to avoid missing any important mail.
- Identifying suspect products following receipt of the report; identifying reporting sources; and assessing reportability and expectedness of events.
- Prioritize cases according to regulatory and project/client requirements.
- Ensuring reports are sent to the client (submission in the client database) within agreed timelines.
- Identify and record quality problems and bring them to the attention of Senior Team Members and Line Managers.
- Streamlined case management processes, ensuring timely submission of quality reports to regulatory authorities.
Drug Safety Associate
IQVIA (FORMERLY KNOWN AS QUINTILES)
10.2018 - 11.2020
- Exposure to all report types and perform all activities from intake to case processing and final review
- Unstructured reports: Clinical trials:- CIOMS, SAE Forms, MedWatch, EDC, Medical records
- Solicited reports:- Patient Support Program (PSP), Non-Interventional study (NIS), Interventional studies, Post approved safety monitoring program (PSMP) and Market research
- Structured reports: Eudravigilance, E2B reports, pharmacovigilance intake (PVI)
- Setting up a follow-up letter to the reporter for further case follow-up as per the applicable guidelines and reporting the case to the respective regulatory agencies
- Meeting the timelines and supporting global regulatory submissions in expedited reporting of ICSRs
- Following client specified SOP's and meeting deadlines
- Performed quality control checks on drug safety reports, ensuring accuracy and completeness of information before submission to regulatory authorities.
- Build a positive, collaborative team environment with project team members.
Education
Post-Graduate Certificate - Healthcare Administration And Service Management
Conestoga College Institute of Technology And Advanced Learning
Kitchener, ON12-2024
Graduation - Bachelor's of Pharmacy
VIGNAN INSTITUTE OF PHARMACEUTICAL SCIENCES
HYDERABAD, TELANGANA12.2017
High School Diploma -
SRI SARADHA JUNIOR COLLEGE
NUZVID, ANDHRAPRADESH05.2013
High School Diploma -
KUMAR PUBLIC SCHOOL
NUZVID, ANDHRA PRADESH05.2011
Skills
Hands-on Argus database and ArisG database
Good knowledge of case initiation, duplicate search, coding, query generation, narrative writing, case assessment and submission
Good knowledge of adverse event reporting, medical terminology, and safety procedures
Confident communication, decision-making skills and leadership qualities
Well-developed interpersonal and teamwork skills to operate effectively as a member of multi-disciplinary teams and contribute to high-quality patient-oriented service
Good knowledge of therapeutic areas
Good oral and written communication skills
Languages: English, Hindi, Telugu, Kannada
Languages
English
Telugu
Hindi
Kannada
Personal profile
- Name: Preethi Bala
- Nationality: Indian
- Date of Birth:18/07/1996
- Gender: Female
- Marital Status: Unmarried
- Languages: English, Telugu, Hindi, Kannada
Timeline
Pharmacovigilance associate I
TEVA PHARMACEUTICALS
09.2021 - 02.2022
Drug safety associate
ICON CLINICAL RESEARCH ORGANIZATION
12.2020 - 09.2021
Drug Safety Associate
IQVIA (FORMERLY KNOWN AS QUINTILES)
10.2018 - 11.2020
Post-Graduate Certificate - Healthcare Administration And Service Management
Conestoga College Institute of Technology And Advanced Learning
Graduation - Bachelor's of Pharmacy
VIGNAN INSTITUTE OF PHARMACEUTICAL SCIENCES
High School Diploma -
SRI SARADHA JUNIOR COLLEGE
High School Diploma -
KUMAR PUBLIC SCHOOL
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