Sree Varsha Datla
San Jose,CA
Summary
Efficient Technical Writer with 1.6 years of experience. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Medical Writer I
Celegence
05.2021 - 12.2022
- Developed Clinical evaluation reports (CERs) and Clinical evaluation plans (CEPs) to comply with current MDR requirements for medical devices.
- Performed adverse event searches in different databases such as MAUDE, TPLC, UK MHRA, TGA to supplement data in the CER.
- Developed search strings specific to the database being used to yield precise, comprehensive data for the device under evaluation.
- Performed literature searches and summarized data to provide adequate evidence in support of all safety and performance aspects of the device.
- Compiled, analyzed and summarized additional data from other sources as needed.
- Served as a regulatory writer on assigned CER projects, collaborating with the project lead to meet all project delivery timelines.
Senior Research Associate
Syngene International
07.2020 - 05.2021
- Handled and dosed animals through various routes of drug administration.
- Had the responsibility to carry out in vivo and ex vivo imaging for client projects in Oncology.
- Managed the Documentation and Raw data handling of client projects.
Chief Medical Office and Patient Safety Intern
Novartis
07.2019 - 03.2020
- Performed a compared review between Pharmacovigilance and Medical device Vigilance.
- Have an understanding of the different safety databases used in Pharmacovigilance like Argus.
- Well Acquainted with MedDRA and safety documents such as PSUR and DSUR.
- Have an insight on ICH, EMA and FDA guidelines.
Participated in Hackathon event, where I gained exposure in Design thinking and prototype building.
Education
Master of Pharmacy - Pharmacology
Manipal College of Pharmaceutical Sciences
Manipal, Karnataka05.2020
Bachelors of Pharmacy -
Manipal College of Pharmaceutical Sciences
Manipal, Karnataka05.2018
Skills
- Excellent written and verbal communication skills
- Active Listening
- Adaptive learner, Effective collaboration and team work
- Regulatory Documents
- Literature Searches
- Learning Strategies
Certification
Completed Writing in the Sciences, an online course authorized by stanford university and offered through coursera.
Timeline
Medical Writer I
Celegence
05.2021 - 12.2022
Senior Research Associate
Syngene International
07.2020 - 05.2021
Chief Medical Office and Patient Safety Intern
Novartis
07.2019 - 03.2020
Master of Pharmacy - Pharmacology
Manipal College of Pharmaceutical Sciences
Bachelors of Pharmacy -
Manipal College of Pharmaceutical Sciences
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