Pranitee Mayekar
Pune
Summary
Highly skilled pharmacovigilance Specialist with over 7 years of experience with extensive experience in case processing, reviewing, and managing safety databases (ARGUS and ARISG). Possess a Master of Pharmacy degree and a strong foundation in pharmacovigilance reporting. Skilled and efficient in medical coding (MEDDRA, WHO DD), training and mentoring junior team members.
Overview
1824
1824
years of professional experience
1
1
Certification
Work History
Safety & PV Specialist
Syneos Health
12.2020 - 04.2024
- Case processing and reviewing experience on safety database (Argus 8.2)
- Worked on therapeutical areas like oncology, diabetes, immunology
- Responsible for triage and book in Individual case safety reports into the safety database for (Literature case, Spontaneous/clinical trials cases/MRP/PSP)
- Being intake person to process handling Pre-Intake activity for mailbox cases, and Post Intake activity for rest of the cases (to maintain Quality in intake level) to managed multiple roles and maintain high quality work standard
- Captured all relevant data into database along with utilizing knowledge of MEDDRA and WHO DD for Coding of medical term (adverse events, medical history, indication) and products (Suspect, Concomitant, historical drug)
- Review and evaluate ICSR information to determine the validity of case, seriousness and expedients following internal policies, procedures and providing detailed explanation if the ICSR is determined as the non-valid Responsible for data entry of individual case safety reports into the safety database and evaluate AE case
- Information to determine required action based on and following internal policies and procedures actively involved in Labelling and assessment of seriousness and expectedness and listedness(Expectedness) of adverse events, causality Statement and summarize all medically significant data into the narrative
- Facilitated follow up based on queries from Data entry/QC/MR or based on inconsistent/missing information in source file
- Mentored junior team members, fostering professional growth through guidance on best practices in industry.
Junior Data Analyst
Cognizant Technology Solution
05.201 - 11.202
- Case processing and reviewing experience on ARISg database for 4 years
- Worked on therapeutical areas like ankylosing spondylitis and Pain management
- Triaged, assessed, and performed data entry of adverse event (AE) and serious adverse event (SAE) information and Coding adverse events accurately using MEDDRA
- Review, extract, and accurately enter AE data from marketed product, adverse event reports received from spontaneous and/or solicited sources including health professionals, sales representative, consumer
- Interpreted case related information including medical coding of events, medical conditions, lab results, and procedures as per MEDDRA, as well as compile complete narrative summaries
- Maintain quality and department standards by reading, understanding, and adhering to organizational standard operating procedures (SOPs)
- Peer reviews the cases and evaluate for accuracy, consistency, and completeness in the safety database against the source document and maintain quality tracker.
- Supported inspections, visits and audits as well as CAPAs management.
- Reviewed production processes and identified potential quality issues along with root cause analysis (RCA)
- Monitoring daily activities of team member (Productivity and Quality tracker) and mentoring team members.
Education
M. Pharmacy -
Modern College of Pharmacy
Pune05-2016
B. Pharmacy -
Modern College of Pharmacy
Pune07.2014
Skills
Triage and data entry of adverse events and serious adverse events (AE/SAE)
Narrative writing and quality review
Knowledge of FDA/EU/ICH guidelines and regulations
Regulatory compliance
Quality assurance processes
Medical coding (MEDDRA, WHO drug)
Case processing and reviewing (ARGUS and ARISG databases)
Accomplishments
- Earned recognition as top performer consistently exceeding targets with Quality.
Certification
Clinical research educational program (CREP)
Timeline
Safety & PV Specialist
Syneos Health
12.2020 - 04.2024
Clinical research educational program (CREP)
M. Pharmacy -
Modern College of Pharmacy
B. Pharmacy -
Modern College of Pharmacy
Junior Data Analyst
Cognizant Technology Solution
05.201 - 11.202
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