SREE

VARSHA

DATLA

adwvov@r.postjobfree.com

310-***-****

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.

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SKILLS

Excellent written and

verbal communication skills

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• 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.

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• 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