Hi, I’m
Aishi Manna
Team Lead-Pharmacovigilance
Kolkata,WB
Summary
Seeking a challenging position in a reputable organization where I can learn new skills, expand my knowledge, and leverage my learnings.
Overview
9
years of professional experience
3
Languages
Work History
Cognizant Technology SolutionsKolkata, West Bengal
Team Lead-Pharmacovigilance | Trainer
06.2017 - Current
Job overview
- Developed enhanced case processing flow as part of project team
- Handled initial and follow-up pharmacovigilance transactions from consumers, healthcare professionals, and attorneys
- Updated and entered appropriate data into safety database and ensured data was captured according to departmental SOPs
- Completed assigned expedited cases to ensure regulatory and client deadlines were met
- Ensured accuracy of coding, which includes selecting appropriate event terms in
- MedDRA and worked closely with the coding department
- Wrote narratives summarizing the events according to departmental SOPs for spontaneous and literature cases through assessment of all source documents
- Experience in processing various types of ICSRs, for example, spontaneous, post marketing study, clinical trial, literature, E2B, Authority cases
- Have experience in triage/book-in, data entry and quality review
- Experience in conducting trainings to new associates to provide process knowledge
- and also conducted training to teammates to give updates
- Have been part of transition-integration phase of project
- TTT and process trainer of team: conducted refresher trainings and shared updates, handled OJC and query handling
- Mentoring of new joinees
- Working as an acting team lead with responsibilities of case allocation, prioritization, associate feedback, operational work (month-end data, associate case quality reports, etc.)
Education
Bharat TechnologyHowrah
Bachelor of Pharmacy (B.Pharm) from Pharmacy
04.2001
University Overview
Marks Obtained:
- First Year: 1st Semester: 8.21 ; 2nd Semester: 7.93.
- Second Year: 3rd Semester: 8.30 ; 4th Semester: 8.29.
- Third Year: 5th Semester: 7.61 ; 6th Semester: 8.06.
- Fourth Year: 7th Semester: 8.22 ; 8th Semester: 8.00.
DGPA: 8.07.
Skills
Team Leadership & People Management
Pharmacovigilance Operations & Regulatory Compliance (ICH-GCP/GVP)
Performance Management, Coaching & Training
Quality Management (RCA, CAPA & Continuous Process Improvement)
Analytical Thinking, Problem Solving & Decision Making
Effective Communication, Interpersonal Skills & Adaptability
ARGUS Safety, MedDRA & Microsoft Office Suite (Excel, Word, PowerPoint)
Accomplishments
- Being a critical member in my team, successfully helped my team during transition and project integration.
- Have been a key player in my team to successfully implemented a new project in my team with case updates, queries and sharing of knowledge.
Academic Project
- Synthesis and Characterisation of Schiff's Bases [1-Benzylidene-2-phenylhydrazine & 2-Methoxy 4-[(2-Phenylhydrazinylidene) methyl] phenol.]
Industrial Training
- Two weeks training at Albert David Limited, Kolkata in the departments of Manufacturing (Oral Liquid, Ointments, Tablet and Small Volume Parenterals), Quality Control and Quality Assurance.
Extracurricular Activities
- Active Participant in various events in college; Organized and managed various cultural events in college being Cultural Committee member
- Engagement team member and have hosted multiple programs in my current organization
Declaration
I hereby declare that the above statements are true to the best of my knowledge.
Kolkata
Date: Aishi Manna
Timeline
Team Lead-Pharmacovigilance | Trainer
Cognizant Technology Solutions
06.2017 - Current
Bharat Technology
Bachelor of Pharmacy (B.Pharm) from Pharmacy
04.2001