Chaitra Maliye

*** ***** *********, ********, ** L6T 0J2

437-***-**** ad3lwb@r.postjobfree.com

www.linkedin.com/in/chaitra-maliye-51a83a80/

Pharmacovigilance Associate

PROFESSIONAL SUMMARY

● 5+ years of experience in the Pharmacovigilance industry

● Expertise in processing ICSR (clinical, spontaneous, patient support and market research) includes data entry, triage, narrative writing, analyzing causality and listedness of adverse events and distribution of cases as per regulatory timelines

● Hands on experience with safety databases (Oracle Argus, ARISg and OARS) and expertise in Adverse Event coding with MedDRA and drug coding with WHODD

● Strong knowledge of Pharmacovigilance (PV) process and aware of regulatory guidelines (ICH GCP, MHRA, US FDA and Health Canada)

● Experienced in triage, processing and review of reports received from Health Canada

● Subject Matter Expert (SME) for Void and Non-Valid (NV) cases

● Excellent command on MS Office, Excel, Word and PowerPoint WORK EXPERIENCE

Lab Technician November 2023 – Present

AGAT Laboratories, Mississauga, ON

• Performed laboratory procedures including preparation of soil and water samples and reagents for pH, Electrical Conductivity (EC) and Cyanide analysis

• Calibrated instruments such as pH meter, weighing balance and EC meters

• Experienced with TCLP, SPLP and Fluoride analysis in water using Ion Selective Electrode (ISE-W)

• Provided general lab support in washing of glassware, cleaning apparatus and waste disposal Drug Safety Specialist 1 July 2017 – May 2022

IQVIA, Bangalore, India

● Triaged incoming reports to determine the seriousness for prioritization of daily workflow as well as for completeness, legibility and validity

● Extracted relevant information from case reports (pre/post marketing ICSR) to create an accurate narrative.

● Generated adverse event queries, liaise with medical reviewers and clients to agree upon the same; Sending out additional information requests to sites/reporters

● Conducted sessions to ensure quality and consistency in process related updates to a smaller group being a quality lead and member of global quality improvement team

● Maintained a record of root cause analysis (RCA), corrective and preventive action (CAPA) collected from team members for the quality errors

● Recognized consistently for highest quality deliverables and certifications in the stipulated time Chaitra Maliye 437-***-**** Page 2

● Communicated the requirements of PV team to the technical team in developing programs to reduce the manual editing of narrative to save up to 40% time in case processing

● In charge of organizing team outings and group activities for the team of 60+ employees Associate Biomodelling Scientist August 2014 – April 2017 CellWorks Research India Pvt. Ltd.

Domain: Development & Quality check of Haeme and Solid cancer model, Strategic Marketing.

● Researched into human biological cell signaling network to identify and validate potential drug targets through Literature search, Drug data banks and Mutation libraries

● Predicted resistance mechanism in therapies provided to understand the recurrence of solid and haeme cancer

● Created and analyzed value adding studies to the work of Key oncology leaders (KOL’s) from USA, as a result we were able to expand our market by 6% in 4 months

● Maintained records and performance details of trainees

● Conducted weekly sync-ups and key notes for team meetings

● Involved in Team project planning and process flow for automation

● Managed Bugs and Enhancement database for the different platforms

● Planned Annual Cellworks sports meet SPORTIVO being a member of sports committee REWARDS AND RECOGNITION

● Spotlight Award for independent contribution towards efficient handling of Batch Reports (May 2022)

● Ovation Award for reducing case inventory and monitoring peers at batch reports (Dec 2021)

● Spotlight Award for exceeding productivity expectations with best quality and for providing support during holidays and beyond business hours (Jun 2021)

EDUCATION AND TRAINING

Internationally Trained Co-op Program 2023

Dufferin-Peel Catholic District School Board, ON, Canada M.Sc. in Bioinformatics and Applied Biotechnology 2014 Institute of Bioinformatics and Applied Biotechnology (IBAB), Bangalore, India B.Sc. in Microbiology and Biotechnology 2012

BMS College For Women, Bangalore, India

VOLUNTEER EXPERIENCE

Registered Volunteer at Canadian Blood Services, Brampton. Volunteer at VTheVolunteers (VTVO) (currently supporting online activities), Bangalore, India.

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