Information High School
Resume:
CURRICULUM VITAE
K.Saivinay : *************@*****.***
CAARER OBJECTIVE
To undertake challenging and responsible assignments in an organization that gives me ample scope and opportunity to learn the aspects of my job and to serve to the best of my abilities and experience. PROFESSIONAL EXPERIENCE
Working as Clinical Publishing and Trial Registrations Associate – II at GSK (formerly Novartis Vaccines) from Sep - 2013 to till date.
Clinical Trial Registrations & Data Disclosure:
Registration of clinical trial protocol information various public databases i.e Ct.gov, EudraCT.
Ensuring the study records are updated accordingly with the amendments and changes in the trial design.
Tracking the records on public databases for updates and ensuring that they are updated with the timelines and complaint with the regulations.
Preparing the data disclosure shells for results posting and extracting the trial results from the source documents CSR, SAS, Protocol & SAP as per the database requirements.
Posting the extracted trial results information on the clinicaltrials.gov and EudraCT. Data anonymization (Redaction):
Identifying the commercially confidential information & personal protection data & marking.
Redaction of clinical study reports as per the internal company & HA guidelines.
Performing the QC of technical redaction properties on final redacted documents Clinical e-Publishing:
Compiling the clinical study reports as per the ICH E-3 guidelines with all the documents and creating the final electronic output compliant with the health authority standards.
DSUR e-publishing with the appendices documents and making it complaint with the health authority standards.
Working knowledge on various regulatory publishing tools like ISI Tool box & Liquent Insight Publisher.
Ensuring that all the ICH documents are available in the eTMF & DMS.
Regulatory operations associate at Freyr Inc, Hyderabad from June 2012 to August 2013 Eudravigilance Medicinal Products Dictionary (EVMPD):
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
Inserted 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
Regulatory Submissions:
Preparation and publication of electronic submissions, NeES and paper submissions
Responsible for the coordination, preparation and submission of various electronic formats such as ANDA, IND, NDA, Annual Reports and amendments worldwide assuring the quality and completeness of the submissions.
Handling all major European and Saudi submissions, Initial MAA, CTA, Variations, (Type IA
/ IB and II), Answer to Questions (A to Q), Supplemental Information submissions, PSUR and NeeS).
Quality check documents, managing those using ISI tool box providing hyperlinks, publishing and validating the submission using EURS, Lorenze & KSA validator.
Provide project management and publishing support for the publishing of regulatory submissions, ensuring timelines are met, the submissions are agency compliant and of quality
Handling team queries
Responsible for Managing Project Timelines
Responsible for implementation of internal standards including standard operating procedures, guidance documents, and policies.
Support compliance with worldwide submission regulations and guidelines TECHNICAL SKILLS
Freyr EVMPD and Freyr DMS
Adobe Acrobat and ISI Tool Box
Basic Knowledge of Regulatory guidelines.
Knowledge in eCTD, SPL submissions.
Operating Systems WIN’95/98/XP, WIN 7.
Expert in MS-office, Excel, and PowerPoint.
Basic Knowledge of primary and secondary research skills. SCHOLASTICS
Maters in Pharmacy from Gland institute of pharmaceutical sciences with an aggregate of 73%
B.Pharmacy from Sai Pranavi College of pharmacy, Hyderabad from with an aggregate of 71%.
Intermediate from Sri Chaitanya Jr kalasala, Hyderabad with aggregate of 82%.
S.S.C from Sitafalmandi High School, Hyderabad with aggregate of 74%. PERSONAL SKILLS
Ability to learn new concepts and assimilate new technology quickly
Good Organizational abilities and strong team building skills.
Self-reliant and can adapt to any kind of environment. PERSONAL PROFILE
Name : K.Saivinay
Present location : 12-10-39, G-2 Venkateshwara Mansion Sitafalmandi, Secunderabad, 500061
Date of Birth : 14thApril 1989.
Sex : Male.
Languages known : English, Hindi and Telugu.
DECLARATION
I hereby declare that all the details furnished above are true to best of my knowledge Sincerely,
K.Saivinay
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