Mansi Mhatre
Mumbai
Summary
Pharmacovigilance Aggregate Reporter with extensive expertise in preparing and analyzing aggregate safety reports, including PSUR/PBRER, DSUR, and ASR. Proficient in consolidating safety data from clinical trials and post-marketing sources to facilitate benefit-risk assessments and signal detection. In-depth knowledge of ICH E2C/E2F guidelines and global regulatory standards, along with MedDRA coding. Demonstrated success in cross-functional collaboration to ensure timely and compliant safety reporting, recognized for analytical precision and dedication to patient safety.
Overview
7
7
years of professional experience
Work History
Pharmacovigilance Aggregate Reporter
Tata Consultancy services
Mumbai
07.2023 - Current
- Prepared and supported PSUR, PBRER, DSUR, ASR, and Line Listings.
- Compiled cumulative safety data from clinical trials, spontaneous reports, literature, and post-marketing data.
- Aggregated adverse event and serious adverse event data for thorough analysis.
- Performed trend and frequency analysis, along with cumulative reviews of safety data.
- Identified new safety signals and changes in known risks to enhance safety profiles.
- Contributed to comprehensive benefit-risk assessments based on evaluated safety data.
- Collaborated with case processing, signal management, medical writers, and regulatory affairs teams.
- Ensured compliance of reports with ICH, EMA, FDA, and other global regulatory requirements.
Senior Drug Safety Associate and process trainer
Tata Consultancy services
07.2019 - 07.2023
- Entered preliminary and follow-up information into the global adverse event database.
- Performing data entry for clinical trial cases, post-marketing cases, literature cases, spontaneous cases, and vaccine cases.
- Coordinated triage and data entry of adverse events, ensuring quality review of cases.
- Participated in triage process for incoming documents to facilitate timely evaluation.
- Wrote full narratives and coded events according to MedDRA, including PSUR comments.
- Developed expertise in company products within oncology and vaccines for accurate data entry.
- Maintained up-to-date knowledge of SOPs and current FDA regulations.
- Provided feedback on challenges and successes during project team meetings with operations manager.
- Trained new associates and conducted refreshers for production staff as per process requirements.
- Executed reconciliation between safety and clinical databases to ensure data integrity.
- Executed reconciliation between safety and clinical databases to ensure data integrity.
- Conducted end-of-line quality checks for RA-submitted cases, maintaining high standards.
- Completed late log activity tasks to enhance operational efficiency.
- Utilized advanced search tools for open case management and housekeeping.
- Delivered RCA and CAPA reports for late cases on behalf of the team.
- Processed cases for end-of-study unblinding, and generated line listings.
- Participated in client audits to verify reconciliation activities and quality checks. Facilitated training sessions on recent updates and provided case-specific feedback to handlers.
Clinical data analyst
IKS Healthcare
07.2018 - 06.2019
- Analysis of hospital and clinical records.
- Recording clinically relevant data into a database.
- Maintaining knowledge regarding medical terminologies.
Education
MSc - Biotechnology
UNIVERSITY OF MUMBAI
Sion01.2018
BSc -
UNIVERSITY OF MUMBAI
Sion01.2015
Skills
- MS office
- Team collaboration
- Client audits
- Process improvement
- Root cause analysis
- Adverse event reporting
- Data entry for vaccine, clinical trials, Post marketing
- Regulatory compliance
- Quality assurance
- Safety database: Sapphire, Argus, and LSMV
- Punctuality
- Time management
- Ethical approach
- Management skills
- Problem solving
- Independent-work
- Team player
- Public speaking
- Communication skills
- WHO-DD
- ICH guidelines
- MedDRA
- Mentorship
Languages
- Hindi
- English
- Marathi
Personal Information
- Date of Birth: 04/29/96
- Nationality: Indian
- Marital Status: Married
Timeline
Pharmacovigilance Aggregate Reporter
Tata Consultancy services
07.2023 - Current
Senior Drug Safety Associate and process trainer
Tata Consultancy services
07.2019 - 07.2023
Clinical data analyst
IKS Healthcare
07.2018 - 06.2019
MSc - Biotechnology
UNIVERSITY OF MUMBAI
BSc -
UNIVERSITY OF MUMBAI