Summary
Overview
Work History
Education
Skills
Rewards and Recognitions
Personal Details
Certification
Timeline
Generic

Madugula Sreeraksha

Bengaluru

Summary

Learning is never ending…! As an energetic aspirant, Proactive, Confident, Team player looking forward to work in a professional environment where I could utilize my knowledge, skills, experience and could give the most dedicated efforts for organization.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Patient safety specialist

Alcon Laboratories India Pvt. Ltd
03.2021 - Current
  • Process case files according to Standard Operating Procedures (SOP)
  • Reassess the data, ensure accurate product selection and assign required event code(s) in the system
  • Complete initial and follow-up reporting assessments as information is received (initial report, follow-up questionnaires, phone calls, investigation findings)
  • Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries
  • Schedule expedited and periodic regulatory reports based on local and international reporting regulations
  • Perform and receive quality feedback on case management and coding
  • Adherence to all corporate compliance guidelines & corporate programs
  • Provide support in reconciliation activities and audit as required
  • Submission of medical device report (MDR) and Vigilance reports to health authorities
  • Ensure that local reports are submitted within timelines as per country specific reporting requirements
  • Prepares and submits US FDA pre-sub, 510(k), and other product submissions according to FDA guidelines
  • Maintains expertise in domestic and international regulations and standards, with a focus on assigned medical devices and regional focus on the US (FDA), LATAM, EU, and CA (Health Canada)
  • Respond to Manufacturing Quality Assurance (QA) requests and change requests
  • Support the preparation of safety document templates, continuous improvement initiatives, or other department projects for clinical safety or post-market surveillance
  • Creation and execution of complex Regulatory Strategies and Plans for assigned medical devices and consumer products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers


Drug Safety Support Specialist

LabCorp Drug Development
12.2019 - 03.2021
  • Assist in processing of Expedited Safety reports to clients, Regulatory authorities, Ethic committee, clients & the Investigators
  • Ensure submission of client-related documents is sent to the clients with designated time frames like ESR reports etc
  • Ensure all incoming faxed serious adverse event (SAE) reports are appropriately stamped, logged into the departmental tracking application, and forwarded in a timely manner to the designated drug safety associate/senior drug safety associate
  • Maintaining ESR/PSR and SAE files in the electronic trial master file (eTMF) records using Veeva vault
  • Monitoring client mailbox for incoming SUSARs and processing them on time to meet timelines
  • Handled Reconciliation and QC activities for the Triageprocess
  • Worked on various projects handled submissions for European countries & United states
  • Experience in maintaining the team & project trackers
  • Coordinating with the teammates in and maintaining the team reports
  • Assist the DSA / Sr.DSA in preparation of materials needed for client and/or investigator meetings and any other duties as assigned by management
  • Provide Administrative support to PV & DSA Personnel e.g.: Word processing, Proofreading etc.

Education

Doctor of Pharmacy -

RGUHS
2019

12th - undefined

KLE University
2013

10th - undefined

SSC board
2011

Skills

  • SAS/Base, SAS/Stat, SAS/Graph, AS/SQL, SAS/Macros, AdvancedExcel
  • Optimized performance using Data Validation on Clinical Trial data using Statistical procedures like PROC FREQ,
  • PROC MEANS, and PROCUNIVARIATE
  • Knowledge on clinical Research data analyzing using SASsoftware
  • MS WORD, ADVANCED EXCEL &POWERPOINT
  • Database: Argus, Eudravigilance, STAR, iTrack - Track Wise, Connexus

Rewards and Recognitions

  

  • Recognition in speed & simplicity category (2021) for cross-skill enhancement and buddy system programs.
  • Recognition as a team player for making complex things appear to be simple (2022).
  • Recognized as proactive member for product experience zone.
  • Cultural Ambassador for best place to work initiative.
  • Trainer for Alcon trainers Club.
  • Certified White belt and yellow belt certification ongoing.

Personal Details

 

  • Name: Madugula Sreeraksha
  • Father’s Name: M. Satyanarayana.
  • Date of Birth: 27th November 1995
  • Languages: Telugu, English, Kannada, Hindi
  • Hobbies: Dancing, reading books
  • Nationality: Indian

Certification

  • Undergoing leadership programme ( Unnati)
  • Completed white belt and yellow belt training.
  • Completed training on Global regulatory Affairs Perspectives
  • Badge cert digital badge from RAPS
  • Base SAS, Advanced SAS, Clinical SAS certifications from NI ANALYTICS, Bangalore.
  • Completed linkedin training on Drug Regulatory Affairs


DECLARATION


I hereby confirm and verify all the information mentioned here, and I take full responsibility for its accuracy and authenticity.


Sreeraksha Madugula



Timeline

Patient safety specialist

Alcon Laboratories India Pvt. Ltd
03.2021 - Current

Drug Safety Support Specialist

LabCorp Drug Development
12.2019 - 03.2021

Doctor of Pharmacy -

RGUHS

12th - undefined

KLE University

10th - undefined

SSC board

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