Md Pharmacology, Clinical Research Pharmacovigilance

Dr. Sonalee Chaturvedi

Professional Experience

Abbott Vascular, New Delhi May, 2008 till July, 2016

Clinical Scientist from July 2015 to July 2016

Global Signal Surveillance process incharge for premarket clinical trials : Analysed the medical device data, drafted the Signal Detection DOP ( Detailed Operating Procedures) and acted as a mentor to less experienced staff

Clinical Affairs representative for Clinical Corrective Action Board meetings and provided medical/safety inputs on individual cases.

Drafted and worked on risk master list for MitraClip/ TriClip device

Drafted the safety and Risk Management sections of the Global Protocol template

Drafted the safety and the risk analysis sections of the annual study reports

Reviewed IFUs, patient guides, Risk Assessment Matrices, Clinical evaluation plans and reports, Investigator Brochures, study protocols, study ICFs, physician training materials, ensured alignment of risk information

Oversaw and coordinated with the CRO and managed the timelines

Clinical Safety Monitor for medical devices including mainly cardiac and peripheral stents (bare metal, metallic and bioresorbabale stents), also; balloons, vascular closure devices, cardiac catheters: May 2008 to July 2015

Global signal surveillance process incharge

Adverse events screening for Japan Regulatory Authority submission

Adverse events screening for Clinical Events Committee end point adjudication (eg. Death. Myocardial Infarction, stent thrombosis). This included reviewing adjudication results and sending queries to the responsible physicians

Investigator Sponsored Studies Protocol review from Safety perspective

Performed Regulatory Affairs, Data Safety Monitoring Board and Ethics Committee submissions

Review: Data Review Plans, Clinical Study reports, Clinical Safety SOPs ( Standard Operating Procedures) and DOPs, Clinical Investigation Plans and Informed consent forms

Contact person for colleagues in the Clinical, Data Management, Quality Assurance and Regulatory Affairs Department

Participated and supported the audits at the New Delhi and Brussels office

Performed the study closure activities from safety perspective

Adverse event processing: Analysed the Adverse Events ( AEs), device malfunctions and MedDRA coded the AEs

Other projects:

Flexibility initiative - Team co leader. Drafted the International Charter on flexible working conditions

Organised cross functional and cross cultural Clinical Team meeting including the venue, budget details, meals and accommodation

Drafted the Telephone Communication Etiquette charter with the team

Rewards and Recognition Intiative: Asia Pacific lead. Planned, executed and presented to the team for this non monetary reward programme.

Asia Pacific Townhall Meeting coordinator- cross functional coordination.

Ranbaxy Laboratories Limited, Gurgaon Dec.10th till May, 2008

Worked in a US based project as Medical Reviewer

Adverse events processing to determine their completeness, relatedness and expectedness including MedRA coding

Inputs/ assisted in preparation of Periodic Safety Update Reports

Signal Detection

Maulana Azad Medical College, Delhi Aug. 2004 till Aug.2007

Designated as Senior Resident in the Department of Pharmacology:

Conducted Lectures and Practical assignments for MBBS, BDS and Nursing Students.

Research Exposure- Worked on following Research Projects:

a. Comparison of mydriatic efficacy of various brands of phenylephrine in rabbits as Chief Investigator

b. Effect of vitamin E and its comparison with omeprazole in Non–steroidal anti-inflammatory drug induced gastric injury in rats as Chief Investigator

c. Evaluation of gastric tolerability, antinociceptive and anti-inflammatory activity of combination Non –steroidal anti-inflammatory drugs in rats as Co- Investigator

d. Gastroprotective effect of melatonin and its comparison in Non–steroidal anti-inflammatory drug induced gastric injury in rats as Co- investigator

Was a part of Adverse Drug Monitoring Program of Maulana Azad Medical College under National Pharmacovigilance Programme

Post Graduate Experience

Worked on Thesis entitled “Evaluation of Herbal Hepatoprotectives in Hepatotoxicity induced by antiretroviral and antifungal drugs”

Delivered MBBS and BDS Lectures and was incharge of practical classes

Publication

Bhupinder Singh Kalra, Sonali Chaturvedi, Vandana Tayal, Usha Gupta (2009). “Evaluation of gastric tolerability, antinociceptive and antiinflammatory activity of combination NSAIDs in rats.”

Indian Journal of Dental Research, 20 (4), 418-422

Paper Presentations

Paper (Poster) Presentation at IPS conference, held in Dec. 2003 entitled “Evaluation of the role of herbal hepatoprotectives in hepatotoxicity induced by antiretroviral drugs”

Paper (Poster) Presentation at 2nd World Conference on “Bio technological Development of Herbal Medicine”

Training Programme Attended

The British Standards Institution (BSI) Training on CE Mark, Risk Management, Clinical Evaluation Reports at Santa Clara, United States

Signal Management Training by, Drug Information Association (DIA), Nice, France

Barnett Drug safety and Pharmacovigilance Training at Santa Clara, United States

Exercising Influence: Building Relationships and Getting Results" training at Brussels, Belgium

Situational Leadership training by Abbott at Mumbai

Dale Carnegie’s Business communication workshop at Gurgaon, Haryana

Good Clinical Practices training at New Delhi

Schedule Y training at Abbott Vascular, New Delhi

Online trainings of ISO14155, medical devices including cardiac and peripheral stents, dilatation catheters, balloons, MitraClip device used for Mitral Regurgitation and TriClip device used for Tricuspid regurgitation, vascular closure devices, percutaneous coronary intervention, Coronary Artery Bypass, peripheral stent implacement, carotid atherectomy, CE marking, ISO14791, and CER regulations

Achievements

At Abbott Vascular, was considered Signal Detection expert and led the Global pro-active Signal Detection.

Effectively managed the adjudication process, despite huge back lock of more than 600 adverse events. This helped to achieve the time line and presentation of Spirit Women Registry data at European Society of Cardiology, 2010

Recognized by the Safety Senior Management for organizing the Asia Pacific Kick off, 2012

Recognized by the Safety Senior Management for the Rewards and Recognition Initiative presentation at the Asia Pacific meeting, 2012

Presentation and training of CEC members at Rotterdam, Netherlands was well appreciated by the Safety Management

Was allowed Belgium relocation to the Abbott Vascular European headquarters

Recognized by the EMEA Management for participation in the Clinical Research mock audit

District topper of Standard X, ICSE board

Was ranked among the Top 5% of the Students in Standard XII

Was ranked amongst top 1% of students in India in the National Talent Search for Physics

Awards

oPACE Award October, for contribution towards audit documents retrieval Mock audit India from APAC Management, 2012

oExtra mile Award for Contribution to SPIRIT WOMEN Study Randomized arm, from Clinical Research Asia Pacific, 2011

oSPOT award from International Clinical Organization, Brussels, Belgium for excellence and dedication to Spirit Women Registry study, 2010

oClinical Champion of the year 2010 award by Clinical Research, India for SPIRIT WOMEN Study

oSpot award for safety presentation from International Clinical Organisation, Brussels, Belgium, 2010

oSPOT Award for the initiative and preparation of the Clinical Safety presentation; from Safety Management, Brussels, Belgium, 2009

oSPOT Award for Contribution to XIENCE V India study from Clinical Research Management Asia Pacific, 2009

Educational Qualifications

Degree

School/ college

Year

M.D. Pharmacology

King George’s Medical University

2001-2004

Internship

Govt. Medical College Hospital, Trichur, Calicut University

1998-1999

MBBS

Govt. Medical College, Trichur, Calicut University

1993-1998

Marks Obtained

Percentage

1st Professional

1167/1800

65%

2nd Professional

605/900

67%

3rd Professional

1606.5/2700

59%

Intermediate (1993)

Queen Victoria Girls Intercollege, Agra

72.6%

High School

Christ The High School, Tundla

88.4%

Hobbies and extracurricular activities

Poetry writing ( English and Hindi)

Play acoustic guitar ( chords)

Languages known

Hindi and English ( reading, writing and speaking)

Malyalam ( speaking)

Personal Details

Date of Birth : October 20, 1975

Email-id : *******.**********@**********.***

Contact Address : 9 Karishma Apartments,I.P Extension -27, Patparganj Society, New Delhi – 110092

Phone No : +91-981*******

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