Namita Naikwad
Mumbai
Summary
Senior Drug Saftey Associate wanted to acquire a challenging position where Knowledge, Creativity, Energy and Management skills can be applied with new learning experience, have around 6 years of work experiece.
Overview
7
7
years of professional experience
8
8
years of post-secondary education
Work History
Senior Drug Saftey Associate
TATA Cosulatancy Services
Mumbai
04.2019 - Current
- Performed quality review and data entry of serious and non-serious adverse event reports following company standard operating procedures, internal business practices to ensure compliance with worldwide safety regulations and corporate policies
- Navigated intricacies of drug safety databases to process adverse event reports.
- Communicated with internal or external contacts to resolve issues related to case processing.
- Performed case processing activities on safety databases
- Tracked completion of all assigned trainings by team members and performed additional duties as assigned within team
- Trained new members on a team into case processing and Handling internal queries associated with case processing and provide appropriate resolution
- Worked as team backup (Spoc) for handling internal trackers
- Involved in task assignments
- Generate follow up request and queries and ensured its closures
- Written descript narratives and labelling all adverse events from various labelling documents
- Molecular lead for particular Molecule
- Awarded as Star Performer Award.
- Prioritize deliverables to accomplished work in established timeframes.
- Compared adverse event source documents against safety database screens for transcription and medical accuracy.
- Trained and mentored new staff to achieve efficiency and maintain daily operational consistency as subject matter experts
Junior Data Analyst
Cognizant Technoloy Solution
Mumbai
03.2017 - 03.2019
- Performed triage, data entry and quality review of serious and non-serious adverse event reports from litigation clinical trial, post marketing studies, spontaneous cases, partner cases, regulatory authority cases and also processed product quality complaints and device related issues
- Performed triage and classification of ICSRs for report type, seriousness, causality, expectedness/labeling and reporting, prioritize ICSR according to regulatory requirements
- Identify significant missing information from reports and ensured its collection by sending follow up letters or queries where appropriate and ensured its closures
- Generated concise, accurate, chronological and well-written case narratives based on information provided both on standard forms and from medical records and other documents of diseases and medications
- Performed adverse event coding using standardized terminology from a medical coding dictionary, such as MedDRA and coding of medications using WHODrug
- Worked as GPO-Specialist to upload Soltraq document in case as per GPO number
- Responsible for additional activities like cases allocation, Tat analysis, monthly error analysis, mentoring junior batches
- Worked as SME in pilot project
- Labelling of adverse events from various labelling documents
- Awarded as Spot light.
Education
Master - Pharmacy (Quality Assurance
INSTITUTE OF PHARMACEUTICAL EDUCATION & RESEARCH, Nagpur University
Wardha 02.2014 - 05.2016
Bachelor - Pharmacy
INSTITUTE OF PHARMACEUTICAL EDUCATION & RESEARCH
Wardha 05.2010 - 05.2014
N.D.D.Y - Naturopathy And Yogic Science
Anekant Swadhayay Mandir
Wardha 11.2014 - 05.2016
Skills
ICSR Case Processing and Quality Review of Spontaneous, Soliciatd , MAP, ASPV , Product Quality Complaints
Expertise in handling AgExchange, Arisg, Writing descriptive narrativesHandling Medra and Ability to prioritize, plan and organize work assignments and able to work under strict timelines Ability to workHandled labelling documents like USPI and CCDs
Subject matter expert
Microsoft Office Word, Power Point, Excel Strong written and verbal communication skillsGood understanding of drug development process and Clinical trials
Timeline
Senior Drug Saftey Associate
TATA Cosulatancy Services
04.2019 - Current
Junior Data Analyst
Cognizant Technoloy Solution
03.2017 - 03.2019
N.D.D.Y - Naturopathy And Yogic Science
Anekant Swadhayay Mandir
11.2014 - 05.2016
Master - Pharmacy (Quality Assurance
INSTITUTE OF PHARMACEUTICAL EDUCATION & RESEARCH, Nagpur University
02.2014 - 05.2016
Bachelor - Pharmacy
INSTITUTE OF PHARMACEUTICAL EDUCATION & RESEARCH
05.2010 - 05.2014