Excel sheet
SRIJA KARUMUDI
Safety Science Specialist
Hyderabad
Summary
As a Safety Science Specialist with a strong passion for regulatory compliance, drug safety and risk management, seeking to enhance skills and knowledge in navigating complex regulatory landscapes and broaden expertise in the fields of drug and medical device safety, quality assurance, and compliance to develop effective strategies that ensure product safety and improve public health outcomes. Ultimately, strive to make a positive impact in the health care industry by promoting the highest standards of safety and regulatory compliance. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
8
8
years of professional experience
6
6
years of post-secondary education
2
2
Languages
Work History
Safety Science Specialist
Fortrea
12.2019 - 03.2024
- Member of T3 (training) who primarily mentors new joiners and also involved in Adhoc activities within team
- One of the SME among team
- Case processing entails keeping track of incoming reports from multiple sources
- Performing clear and correct data capture of cases in compliance with work instructions, SOPs, and norms
- Assuring that the events' expectedness, causality evaluation, and severity criteria are correct
- Ensuring MedDRA coding in accordance with MEdDRA term selection
- Routing case to next process as needed, as well as doing quality reviews and quality checking/validation checks on cases
- Maintaining thorough awareness of SOPs, Work Instructions (WI), guidance materials, and directives related to safety management, reporting, and pharmacovigilance
- Knowledge of other procedural papers, such as SOPs, and how they affect safety
Drug Safety Associate (Operations Specialist I)
IQVIA
04.2016 - 11.2019
- Performed quality check of case against source document and entering any data found relevant during assessment, quality check of coding, events, indications and patient history
- Performed quality check of coding of suspect products as well as concomitant drugs
- Checked if all data has been provided in narrative
- Provided timely feedback to team members
- Took feedback sessions and training for associates based on QC trends
- Data entry from source document on to safety data base and appropriate quality review
- Complete case processing (case data entry, labeling, approval numbers and narrative writing)
- Discuss source documents and coding conventions with pharmacovigilance physicians
- Clarification of unclear or illegible information from Local Safety Officer or call center and customer communication as per project requirement
- Processed medical records and E2B documents.
Education
B.Pharmacy - Pharmacy
Sir CRR College of Pharmacy
Eluru, Andhra Pradesh 10.2009 - 05.2013
M. Pharmacy - Pharmaceutics
Marri Laxman Reddy College of Pharmacy
Dundigal, Hyderabad 10.2013 - 08.2015
PG Diploma in PV, CDM And CR -
Syncorp Institute
Silk Board, Bangalore 01.2016 - 06.2016
Skills
End to end processing of SAEsundefined
Personal Information
Hobbies: Music and quilling make me cheerful.
Behavioral Skills
- Problem-solving
- Communication and inter-personal
- Critical thinking
- Analytical mindset
- Organizational
- Multi-tasking
- Time management
- Leadership
- Flexibility and adaptability
- Detailed and result-oriented
- Decision-making
- Pro-active
- Teamwork and collaboration
Courses Completed
Completed an advance PG diploma in CR, CDM and PV from Syncorp Institute, Silk board, Bangalore from January 2016 to April 2016.
Awards
- Received Bravo from the manager for 100% quality in case processing (IQVIA)
- Received top performer from the manager for standing at 3rd position in stack ranking, out of 80 (LABCORP)
Projects
Performed a project on enhancement of dissolution rate of Telmisartan by solid dispersion technology
Timeline
Safety Science Specialist
Fortrea
12.2019 - 03.2024
Drug Safety Associate (Operations Specialist I)
IQVIA
04.2016 - 11.2019
PG Diploma in PV, CDM And CR -
Syncorp Institute
01.2016 - 06.2016
M. Pharmacy - Pharmaceutics
Marri Laxman Reddy College of Pharmacy
10.2013 - 08.2015
B.Pharmacy - Pharmacy
Sir CRR College of Pharmacy
10.2009 - 05.2013
Quote
The way to get started is to quit talking and begin doing.
Walt Disney
Work Preference
Work Type
Full TimeLocation Preference
RemoteOn-SiteHybridImportant To Me
Work-life balanceCareer advancementCompany CultureFlexible work hoursWork from home optionAccomplishments
- Trained new joiners and people with low quality in QIP to enhance and develop their quality
- Strong knowledge of databases and project specific conventions
Software
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