Data Management R D
Resume:
RESUME
Kalpana Gopagani ****************@*****.***
CAREER OBJECTIVE
To build a career which enables me to maximize my professional talent and develop my inner potential and contribute my wellbeing towards development of the organization. I strive to enhance the effectiveness and efficiency of all functions for excellence through dedication and commitment in my entire endeavor in a dynamic organization, this would also facilitate continuous learning.
PROFESSIONAL SUMMARY
Around 9 years of experience in Regulatory Operations, Submissions, RIMS, Analytical R&D, Analytical validation, and Instrumentation.
Have good experience in Data management which is Regulatory information management systems.
Handled end to end updating the databases with quality.
Involved in updating databases for the various regulatory information into the tool such as safety, drug substance and product information.
Have good knowledge of Regulatory document reviews, Compilation and Submission/ Publishing for eCTDs (ANDA, NDA etc.)
To ensure for dispatch of the Regulatory Dossiers for markets like EU, US-FDA, Health Canada after thorough review.
To check/review, linking, bookmarking, and rendering of multiple documents as per regulatory requirements.
Hands on experience in XEVMPD compilation, translate the compiled data using XEVMPD TOOL and submit to the EMA through EVWEB.
Have good knowledge of ARIS register, Regdb, Vardb, Novarim.
Have good Knowledge in US FDA, EMA, ICH, eCTD regulatory guidelines.
Self-confident with excellent verbal communication and writing skills.
Good Presentation skills onboarded and given training on different platforms.
EMPLOYMENT
Organization: Novartis, India
Designation: Specialist
Period: September 2019 to March 2023
Publishing
Have exposed to different tools such as Databases Regdb and Vardb, Docubridge, Novarim
Responsibilities
Exposure to RIMS as Data management specialist handled tools such as Regdb,vardb and Novarim
Daily activities included but not limited to, updating databases Regdb and Vardb, drug substance, products, safety creation and information protocols. Part of Month end process validating the data along with quality checks, attending IDMP meetings, participated in overseeing testing for upcoming Novarim tool.
Lead projects from start to launch, including kick off meetings with the walk through of high-level timelines and the role/responsibility matrix.
Conducted internal and cross functional team meetings to gather current progress and identify any blockers. Monthly and Quarterly walk through to the leadership team of the project progress.
Brainstorm with peers and business to identify potential threats to the project and create a Business Continuity Plan to mitigate the risks.
Participated in Scope delivery sessions and set realistic project completion deadlines and consistently met the deliverables.
Recognized as Best Employee for my work in 2021.
PREVIOUS ORGANIZATION
Organization: DXC Technology, India.
Designation: Professional 1
Period: June 2016 to September 2019
Publishing
I have been exposed to different tools such as CARA, ISI publisher, Ectd express, Lorenz e-Validator.
Responsibilities
Undergoing rigorous training and working for one of the biggest clients of the pharma industry.
My work is to perform formatting, publish in ISI publisher and perform QC. During this work process we face a lot of challenges and there will be multiple issues during this procedure. So, we should take spontaneous decisions, which should reflect with highest quality report. I have performed multiple live submissions with 100% quality report.
Publishing of IND regulatory applications for the client Bristol Myers Squibb and Validation of Submissions using Lorenz e-Validator.
PREVIOUS ORGANIZATION
Organization: FREYR SOLUTIONS, Hyderabad, India.
Designation: Trainee Regulatory associate
Period: April 2014 to June 2016
Publishing
Responsible for end-to-end publishing and timely completion of submissions ensure deliverables and resolve any issues experienced during the submissions and by advising cross-functional teams as needed and ensuring timely deliverables.
Responsibilities:
Understand and follow internal standards including standard operating procedures, guidance documents, and policies throughout the lifecycle of the submission.
Create and verify bookmark structure and hyperlinks to ensure submission-readiness and end to end submission activities.
Perform document-level and final quality control reviews of submission PDF files.
Publishing activities include Paper publishing, NeeS publishing, eCTD publishing.
eCTD submission includes Annual Reports to USFDA and NeeS submissions.
Tracking the status of the submission and updating the submission status in the tracker.
Archiving the submission in database.
Performing document level QC and submission level QC.
Involving in trouble shooting activities in publishing tool related and other queries.
Done Document level publishing for PMA integra client for medical devices and performed Quality check and delivered the project in the given timeline.
XEVMPD submission for EU region, Aris register for JNJ, Freyr submit tool
European pharmacovigilance legislation requires all Marketing Authorization Holders in Europe to
electronically submit detailed, XML-based product records to the EudraVigilance Medicinal
Product Dictionary (XEVMPD). XEVMPD is designed to support collection, reporting coding and
evaluation of Medicinal Product Drugs in version 1.0 and Investigational Medicinal Products in
version 2.0. When the EVMPD receives and EVPRM, it processes the message and generates and
acknowledgement message, XEVPRM_ACK in SML format. XEVPRM is based on XML.
Responsibilities:
Received the Authorized Medicinal product information from the Client for registration of drug products in the XEVMPD database and segregated it systematically for easy access
Verified and reviewed the product information for the availability of the mandatory information by the Client.
Inserted the Authorized Product details in XEVMPD tool to create Extended Eudravigilance product report message (XEVPRM) for the products.
Submitted product information (XEVPRM message) to the EMA Eudravigilance database through the EVWEB Trader
EDUCATION
Master's in quality assurance and Pharma Analysis, Palmuru University India 2012
Bachelor's in pharmacy, JNTU University 2010
SKILLS
ICH, WHO-GMP, EU guidelines and Dossier preparation for EU region.
Knowledge of CMC, NDA, ANDA.
Tools exposure
ISI toolbox, Adobe Acrobat Pro®,ISI publisher XEVMPD Tool, ARIS Register, SharePoint, EVMPD, CONNECT, EV WEB, CARA, e-CTD express.
Good knowledge of MS Office, Excel, XML formatting.
AREAS OF INTEREST
Regulatory Affairs & Operations.
Regulatory information Management systems
Project Management
Business Analyst
Client services, compliance.
Declaration:
I hereby declare that the above written particulars are true to the best of my knowledge and
belief.
(Kallpana)
Contact this candidate