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
undefinedTimeline
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
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