Medical Writer Technical
Resume:
SREE
VARSHA
DATLA
********@*****.***
San Jose, CA 95134
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.
PROFESSIONAL SUMMARY
Celegence - Medical Writer I
Bengaluru, India • 05/2021 - 12/2022
Syngene International - Senior Research Associate
Bengaluru, India • 07/2020 - 05/2021
WORK HISTORY
Developed Clinical evaluation reports (CERs) and Clinical evaluation plans (CEPs) to comply with current MDR requirements for medical devices.
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Performed adverse event searches in different databases such as MAUDE, TPLC, UK MHRA, TGA to supplement data in the CER.
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Developed search strings specific to the database being used to yield precise, comprehensive data for the device under evaluation.
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Performed literature searches and summarized data to provide adequate evidence in support of all safety and performance aspects of the device.
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Compiled, analyzed and summarized additional data
from other sources as needed.
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Served as a regulatory writer on assigned CER projects, collaborating with the project lead to meet all project delivery timelines.
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• Experienced with medical writing tools (e.g., Zotero) Handled and dosed animals through various routes of drug administration.
•
SKILLS
Excellent written and
verbal communication skills
•
• Active Listening
Adaptive learner, Effective
collaboration and team
work.
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• Regulatory Documents
• Literature Searches
• Learning Strategies
Manipal College of
Pharmaceutical Sciences
Manipal, Karnataka • 05/2020
Master of Pharmacy:
Pharmacology
EDUCATION
Thesis: Comprehension of a
safety database and a
compared review between
Pharmacovigilance and
Medical device vigilance.
•
Presented a Poster on : An
Insight into the
Immunological Checkpoint
•
Manipal College of
Pharmaceutical Sciences
Manipal, Karnataka • 05/2018
Bachelors of Pharmacy
Inhibitors in cancer at
Innopharm3 Conference,
held at Goa.
Presented a Poster on : A
review of Anticancer
Property of Nimbolide at
International Congress of
society for
Ethnopharmacology.
•
• 8.66 GPA
Awarded distinction
certificates for the years
2015,2016 and 2017.
•
Presented a poster on :
Role of Gut Microbiota in
Diabetes Mellitus at
Pharmaquora.
•
• 8.20 GPA
Completed Writing in the
Sciences, an online course
authorized by stanford
university and offered through
coursera.
CERTIFICATIONS
Novartis - Chief Medical Office and Patient Safety Intern Hyderabad, India • 07/2019 - 03/2020
Had the responsibility to carry out in vivo and ex vivo imaging for client projects in Oncology.
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Managed the Documentation and Raw data handling of client projects.
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Performed a compared review between
Pharmacovigilance and Medical device Vigilance.
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Have an understanding of the different safety databases used in Pharmacovigilance like Argus.
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Well Acquainted with MedDRA and safety documents such as PSUR and DSUR.
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Have an insight on ICH, EMA and FDA guidelines.
Participated in Hackathon event, where I gained
exposure in Design thinking and prototype building.
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Contact this candidate