Kamma Sudeepthi

KAMMA SUDEEPTHI PROFESSIONAL EXPERIENCE Hands on Experience (2018 - Present) • Worked on multiple workflows with various functions (Global Clinical Operations (GCO), Global Patient Safety (GPS), Global Regulatory Operations (GRA) • Creating and updating Virtual Documents (“Digital Dossier”). • Creating and verifying bookmark structure and hyperlinks to ensure submission-readiness • Handling Ad-hoc requests in line with SOP and SLA of GRA OPS to meet timelines with high quality • Performing Submission readiness for all types of documents including PDF, Word for all the disciplines • Report Publishing for all Patient Safety Reports, Clinical (Safety Management Plan), Nonclinical Reports using RLP Manager • Will enter the data in Excel or PDF • Able to work independently for solving the issues • Face to face Contact, Skype Meetings, email communications with Many Stakeholders • Ordering, formatting, uploading, approving the literature files • Converting the Excel files to Pdf files which are used for PSMF Documents • Familiarity with departmental Standard Operating Procedures and work instructions • Always keep an update of the current global regulatory submission standards • Conversion of PDF to word, Word to PDF, EXCEL to PDF • Copy and pasting • Copywriting Additional Knowledge • e-CTD and Paper format Submissions • Global Health Authorities (EMA, FDA and ROW) PAREXEL INTERNATIONAL, CHANDIGARH (2017 - 2018) • Adhere to client compliance Standards • To Screen the Literature articles based on PICO Criteria of the project by checking the data in Abstracts • Further Checking the data in the relevant articles by reading the full text • To extract the data from the included studies in the extraction grid • To perform QC for the data extraction • Involved in pre publishing activities like hyper linking and creating bookmarks by using LIQUENT Smart Desk for pdf • Gained knowledge of Post Publishing activities (External linking, Validation) • Owns the responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of Regulatory Outsourcing Services and the client • Gained knowledge on populating submission trackers • Familiarity with departmental Standard Operating Procedures and work instructions • Always keep an update of the current global regulatory submission standards Startech labs, Hyderabad • Assisted in quality control and quality assurance departments TECHNICAL SKILLS • ISI toolbox • eCTD reviewer • MS Excel • MS Word • Power point • Liquent RIMS • Lorenz Validator • Secondary research (Embase, PubMed, Cochrane) • Systematic Literature Reviews • Targeted Literature Reviews (2015 - Approx. 6 Months) • eCTD Manager (Done the Trainings) • PDF Conversion • WORD conversion • EXCEL conversion • Copy Typing • Data Entry STRENGTHS • Good communication skills • Positive & self-motivated • Adaptable • Decision making skills • Sincere & determined to work • Good at time management • Hardworking ACHIEVEMENTS • I have been awarded with Gold medal for an excellent academic performance in B. PHAMACY. • Secured 1st rank in all the semesters of B. Pharmacy. • Secured 41st rank in AP-PGECET • Secured 21st rank in MU-OET 2016 • Volunteered in NSS camps in rural areas for creating an awareness in people EDUCATION M. Pharmacy: Manipal University Manipal college of pharmaceutical sciences B. Pharmacy: Andhra University Shri Vishnu college of pharmacy Class XII: Andhra Pradesh State Board Sri Chaitanya junior college Class X: Board of secondary education Abhyudaya high school Of Andhra Pradesh