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Medical Safety

Location:
Lexington, MA
Posted:
December 09, 2016

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Resume:

Kranti Narvekar **** Lexington Ridge Dr., Lexington, MA 02421

469-***-**** acxt7j@r.postjobfree.com

COVER LETTER

December 9, 2016

Lancesoft Inc

Lexington, MA

Re: Drug Safety Associate

To Lancesoft Inc. Recruiting Department,

I was excited to learn about your recent Drug Safety Associate in the Lexington area. My family and I just relocated to Lexington, MA from Fort Worth, TX where I was working as a Medical Safety Specialist with Alcon (a division of Novartis).

In reviewing the positions posted, I believe I possess the medical safety knowledge for the Drug Safety Associate position depending on the specific position requirements and can immediately make an impact in the role.

I have a Master’s in Nutrition and a Bachelor’s in Ayurvedic Medicine & Surgery and bring a comprehensive understanding of clinical medicine. I have had exposure to safety reporting during clinical trials as well as to medical safety and post-marketing safety surveillance in a pharmaceutical company.

While working at ACRC, a Clinical Investigational Site and Site Management Organization, I understood and followed principles of ICH and GCP regulations while conducting clinical trials. In addition, I have demonstrated strong attention to detail in tracking 40 customer product complaints per day for over 20 eye care products as a medical safety specialist at Alcon. I also understand the process for ensuring compliance with the FDA and other regulatory agencies.

My resume is attached for your review.

I would welcome the opportunity to discuss how my background could contribute to one of your clients in the Lexington area. I can be reached at the contact information listed on this letter. Thank you for consideration.

Sincerely,

Kranti Narvekar

Kranti Narvekar Resume, Page One

A medical professional with background in medical safety, product quality, clinical research trials, FDA compliance and medical recordkeeping. Possess knowledge of ICH, GCP, GVP guidelines, Informed Consent process for clinical studies and knowledge of MedDRA coding and Argus database. Able to perform database/literature searches with knowledge of medical terminology. Proficient in MS Word, Excel and PowerPoint.

PROFESSIONAL EXPERIENCE

Alcon, a Novartis Company, Fort Worth, TX

Medical Safety Specialist May – Jul 2016

Reviewed and managed 30 cases per day concerning quality and complaints for over 20 Alcon eye care products throughout the US. Ensured compliance with FDA, local and international regulations.

Managed quality and adverse event complaint records for assigned therapeutic areas using designated safety systems. Consistently met or exceeded entry of complaints within the required timeframes.

Tracked over 40 complaints per day in itrack database which reduced the pending complaint rate.

Coordinated follow-up to obtain missing and additional information and samples from the consumer as well as Eye-care professional services. Documented information upon receipt which included correspondence, medical records and service requests.

Reviewed investigation findings when complete to ensure customers were satisfied after receiving refund or replacement products and cases were closed accurately to comply with audits and queries from FDA.

ACRC Trials, Plano, TX

Clinical Research Intern Mar – Apr 2016

Supported the CRC in facilitating and coordinating the daily clinical study activities of assigned studies including assisting in developing clinical budgets and completion of case report forms in EDC system. Under supervision of the CRC, reported Adverse Events, Serious Adverse Events to the Sponsor and IRB in a timely manner

Worked on 4 Phase II-IV pharmaceutical and device studies related to Influenza, Migraines, Acne and Diabetes.

Reviewed assigned protocols including study procedures and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.

Scheduled 10-12 subject visits per week and ensured that and treatments during visits were conducted and coordinated subject follow up.

Participated in and gained knowledge of the informed consent process.

Coordinated sponsor visits and attended sponsor monitoring visits to ensure study related documents were available to site monitors from Sponsors, CROs, and FDA during audits.

Assisted in development of study materials and tools including flow-charts and visit schedules to facilitate execution of studies.

Organized and maintained study files, including regulatory binders, study specific source documentation and other materials as required.

Kranti Narvekar Resume, Page Two (Continued)

Ayurvedic Medical Practitioner, Sawantwadi, Maharashtra, India Family Practitioner May 2003 – Apr 2005

Evaluated, diagnosed and treated an average of 10 patients per day.

Janakibai Hospital, Sawantwadi, Maharashtra, India

House Officer, Internal Medicine Unit Nov 2002 – Apr 2003

Met with over 20 office patients and 50 in-patients per day, reviewed patient histories, conducted physical examinations and assisted in minor surgical procedures.

Conducted various procedures including phlebotomies, bedside tests, patient care procedures during management of admitted patients.

Accurately maintained patient charts and provided progress reports at unit in-charge Physician rounds.

EDUCATION

M.S., Nutrition

Texas Woman’s University, Denton, TX 2009 – 2012

GPA – 3.76

Bachelor of Ayurvedic Medicine & Surgery (B.A.M.S.)

Bhaisaheb Sawant Ayurved Mahavidyalaya, University of Mumbai, India 1996 – 2002

CERTIFICATIONS AND COURSES

Attended the ACRP Annual North Texas Chapter Fall Symposium (Tools to Help Clinical Sites Optimize Performance and Maintain GCP Compliance) – Nov. 2015

Registered Ayurvedic Physician (India)



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