Fnu

Juaria

Naseer

Drug Safety

Associate

Fnu Juaria Naseer

571-***-****

adk2vq@r.postjobfree.com

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Skills

● Experience in Clinical Research documentation.

● Quality Assurance as per standard protocols.

● Knowledge in Pharma Manufacturing and Marketing.

● Sound knowledge of disease processes and prevention.

● Good Communication skills and work ethic.

● Experience working with Safety Databases, ARGUS, Microsoft office programs including Word, Excel, PowerPoint, Visio and Project.

● Coding of reported event terms, patient Medical history, and Labs using MedDRA and drugs using WHO drug dictionary and Company drug dictionary.

● Expertise in data entry and case processing based on ARGUS safety database.

● Evaluating and reviewing of case if SUSAR and reporting the same to FDA.

● Conducting casualty assessments.

● Familiarity with FDA guidelines, experience with submissions ECTD & ESG (electronic submission gateway)

● Knowledge of various submissions types such as labeling supplements

● Exceptional scientific and technical skills support for project management, regulatory affairs, quality assurance and compliance as needed.

● Generating comprehensive and accurate medical narratives from the collected AEs/SAEs from source documents.

● Perform safety review of relevant safety database timelines and regulatory reporting requirements.

● Perform safety review of clinical and diagnostic data.

● Synthetic and analytic skills as well as accuracy in daily work required.

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Experience

Romark / safety specialist

FEB 2018 – DEC 2020,Florida, US

● Equipment Inspection and evaluation of workplace environment, or practices to ensure compliance with safety standards and government regulations.

● Behavioral analysis.

● Hazardous waste handling.

● Training action plan, report and assessment, feedback and evaluation.

● Report any accident investigation findings.

Zubi Medical Hall / Pharmacy Technician

MARCH 2009 - 2013, Vijay Nagar Colony, Hyderabad, Telangana, India

• Customer and Doctor interaction

• Payment collection

• Preparing prescription labels

• Maintenance of equipment

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Education

NIMS UNIVERSITY / MSC Gen Chemistry

Jaipur- Rajasthan, India

2013

Osmania University / B.Ed. Sciences

Hyderabad, Telangana, India/ April 2006

Osmania University / BSC Life Science

Shadaan Degree Collage, Hyderabad, Telangana, India/ July 1999

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Awards

CNA Certification / ASPIRE Inc.

VA, USA

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