Quality Medical

Curriculum Vitae Dr. Vishal Giram

Contact details:

MOBILE NO: 976-***-****

D502, Ritu world, Barrage road

Badlapur (w) 421503 EMAIL ID: ************@*****.**.**

Objective:

To use my knowledge of medical field and clinical research for building career in clinical research industry

Professional Experience:

Currently working in Tevapharm India Pvt Ltd as a Senior Executive at Customer Complaints Center

since 20 Aug 2013.

Current job profile (Senior Executive at Tevapharm India Pvt Ltd, May 2014 Current):

Ensure process related metrics for the team with respect to:

Productivity

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Case & Team Quality Scores

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Ensure Schedule Adherence for the Team through leave management and rosters

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Contribute to Recruitment (measure through participation in screening and interviewing

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candidates)

Identify development needs and ensure training fulfillment for the team (to be tracked

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against the training plan)

Effective utilization of resources through cross training

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100% adherence to SOPs & guidelines

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Ensure Schedule Adherence for the Team through leave management and rosters

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Implement and revise department SOPs and Work Instructions as needed.

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Previous job profile (Executive at Tevapharm India Pvt Ltd, Aug 2013 May 2014):

Receive, classify, and route all product quality complaints and adverse event reports

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received via live phone calls, voicemails, emails, letters or any other type of source

document (structured or unstructured).

Initiate the investigation by notifying the concerned manufacturing/packaging site

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Create a record of the complaint received in TrackWise and classify the records into Non

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Complaints, Quality Complaints, Adverse Events and Potential Field Alerts

Request the Manufacturing/Packaging sites for appropriate investigation

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Send an acknowledgement/closing letter to the patient according to need of the

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complaint

Initiate the replacement/reimbursement of the product, according to the situation and

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policies

Arrange a FedEx/UPS pick up for the return sample/product from the complainant for the

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further investigation at the manufacturing/packaging site

Reconciliation of the reports received from different departments and ensuring all the

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report are entered in Trackwise

Implement SOPs and Work Instructions as needed.

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Previous job profile (Quality reviewer and Trainer at Cognizant Technology Solutions, May 2012

Aug 2013):

• To ensure individual case safety reports processed by case processing associate is medically

relevant, complete and accurate

• Ensure scientific rigor through accurate check of complete and consistent data entry of adverse

event reports

• Use MedDRA and business guidance documents to check medical history, drugs and adverse

event terms coded by case processing associates

• Check narrative summarizing the essential details of case

• Work with case processing associates and medical reviewer to improve quality

• To respond queries raised by the case processors and provide adequate feedbacks

• To conduct on boarding training for newly hired associates

• Ensure each associate is trained on updates in case processing conventions

• To conduct workshop/ training for bottom performing associates with respect to quality of case

Previous job profile (Case processing associate at Cognizant Technology Solutions, Sep 2010

May 2012):

• Booking and processing adverse event report in ARGUS database

• Prioritizing cases while processing

• Narrative writing

• Coding adverse events using MedDRA

• Seriousness assessment of the events

• Labeling assessment of the events

• Processing Literature reports

• Communicating with Country Pharma Organizations for queries regarding adverse events

report

Key skills:

• Bachelor of Homoeopathic Medicine and Surgery

• Advance Post Graduate Diploma in Clinical Research and Management

• Well versed with MedDRA coding

• Well versed with ARGUS database

• Good knowledge of Microsoft Word, Excel and PowerPoint

• Leadership quality

• Presentation skills

• Languages known English, Hindi & Marathi

Eductional qualification:

• One year full time Advance Post Graduate Diploma in Clinical Research and Management

completed in 2010

• Four year Bachelor of Homoeopathic Medicine and Surgery course with one year training

passed in 2009 with first class.

Extracurricular activities:

• Attended 12th national homoeopathic conference in 2006

• Attended 13th national homoeopathic conference in 2007

• Active participation in college annual cultural events

• Attended one day seminar on medical writing

Declaration:

I hereby declare that above mentioned details are true to the best of my knowledge.

(Dr. Vishal Giram)

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