Project Manager
Resume:
gouspasha. mohammed
Flat no ***, Nizampet road, Hyderabad, India
e-Mail : acvnwo@r.postjobfree.com
Ph. No : 871-***-****
Career Summary
Over 3 years of experience in Leading Regulatory service Provider as Regulatory Associate.
Expertise in Regulatory document Review, Compilation, Publishing and Validation for eCTD, NeeS and Paper dossiers.
Have published more than 300 submissions for Europe, US, SFDA and African markets.
Have published around 150 SPL submissions and site registrations to USFDA.
Have published PMA, 510(K) submissions for Medical devices.
Perform quality assurance of published output for completeness and correctness.
Verify that final customer and/or agency deliverables meet and are as per all applicable regulatory standards.
Responsible for all project related client communication.
Responsible for ensuring that the project is compliant as per ISO standards.
Certified ISO 9001: 27001 internal auditor.
Have represented publishing project in external ISO Audit.
Represent publishing project in monthly PMO meeting.
Hand on experience on Pharmacovigilance.
PROFESSIONAL EXPERIENCE
Designation: Regulatory Professional 1 (Sep 2015- till date)
Organization: CSC.
Project Title: Regulatory Submission.
Responsibilities:
Publishing activities (Compilation of application as per submission planner, publishing of eCTD, Paper Output/ Dossiers and NeeS Submissions to various Agencies).
Provide naming conventions different files as per standard specifications.
Conversion of different file format of the PDF as per specifications.
Life Cycle Management of Drug Product.
Ensure that the all the files in dossier are as per specifications.
Designation: Regulatory Associate (Jan 2013- Aug 2015)
Organization: Freyr solutions.
Project Title: Regulatory Submission.
Responsibilities:
Publishing activities (Compilation of application as per submission planner, publishing of eCTD, Paper Output/ Dossiers and NeeS Submissions to various Agencies).
Provide naming conventions different files as per standard specifications.
Conversion of different file format of the PDF as per specifications.
Life Cycle Management of Drug Product.
Ensure that the all the files in dossier are as per specifications.
Post Publishing activities (External linking, Validation of submission).
Perform quality check of submission prepared and compiled by team members.
Responsible for the Quality of all Deliverables and submission.
Collecting requirements & documents from the client & review of those documents.
Responsible for Managing Project Timelines.
Responsible for implementation of internal standards including standard operating procedures, guidance documents, and policies.
Communicates any Project Concerns/Issues to Project Manager / Client.
Support compliance with worldwide submission regulations and guidelines.
Maintaining and keep the immediate supervisors informed of any risks/issues within projects/teams.
Project Name: EudraVigilance Medicinal Products Dictionary (EVMPD)
Responsibilities:
Received the Authorized Medicinal product information from the Client for registration of drug products in the EVMPD database and segregated it systematically for easy access.
Verified and reviewed the product information for the availability of the mandatory information by the Client.
Assigned the Authorized Product details in EVMPD tool to create EudraVigilance product report message (EVPRM) for the products.
Submitted product information (EVPRM message) to the EMA EudraVigilance database through the EVWEB Trader.
Follow up and resolve any queries from the agencies.
Project Name: SOP Rationalization
Responsibilities:
Review existing SOPs according to the objectives specified in the project guidelines.
Put forward any changes in the global regulations and company policies.
Merging of different sops where ever possible to generate a single standard procedure for work flow.
Identifying of obsolete SOPs across the globe and generate new SOPs where ever appropriate.
Work collaboratively with key stakeholders across functions and geography.
Organization: Gratisol Laboratories.
Designation: Intern Drug safety.
Main Duties and Responsibilities:
Receive case from central receipt unit.
Perform the case assessment.
Perform duplicate check.
Checking the seriousness of the case.
Coding using Medra and WHODD
Forwarding the case to medical review department.
Locking the case and forwarding case to quality department.
Following up the case wherever follow up for the cases are required
Submission of the cases within the scheduled deadlines.
Environment / Tools
Lorenz docuBridge
ISI publisher and Toolbox
Liquent insight publisher
Lorenz eValidator
EURS validator
e-Submitter
e-Copy
SPL X-forms
Argus safety database.
XML
EVMPD
DMS
PROFESSIONAL EDUCATION
Ms in Drug Discovery and Development from university of Sunderland, United Kingdom,
B. Pharmacy from PRRM College of Pharmacy from JNT University, India.
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