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Drug Safety

Location:
Rochester, NY
Posted:
May 19, 2014

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Resume:

Sunil Aggarwal, MD, DMRD, MBBS, MBA

Master Black Belt in Lean Six Sigma

Email: acd68f@r.postjobfree.com

*** ******** **. ***. *,

Rochester, NY 14620

Ph: 717-***-**** (cell)

Synopsis of my Skills/Qualifications:

I am an MD with MBA and Master Black belt in Lean Six Sigma, presently in New

York, USA in Radiology multimodality services, research and admin with a combined

experience of 14 years in clinical practice with clinical research and medical device

development. I am an approved reader and a Medical monitor/adjudicator for major

pharmaceutical companies and with pharmacovigilance, regulatory and

administrative/compliance experience (OSHA). I have formulated training modules for

my colleagues and core lab/CRO.

I have regulatory and Pharmacovigilence experience while keeping customers’ need at

the foremost including bid defenses and budget approvals. I have experience in

GCP/GPV and ICH guidelines with regulatory bodies (FDA 21 CFR Part 820, ISO

13485 and HSP/BMO), at a local and international platform (DRA-ROW). Client and

site management are an important ingredient to the success of a project and I have

mechanisms in place to achieve. I have regulatory and pharmacovigilance (drug

safety) experience while keeping customers’ need at the foremost including bid

defenses and budget approvals. I have expertise in reporting PADERs, PSURs,

SUSAR, SAEs through AERS and NDA/IND annual reports with working knowledge

of MedDRA coding and expertise in performing data entry of adverse event reports

into global safety databases and knowledge of PV related platforms. I have worked

with ARGUS and ARISg. Client and site management are an important ingredient to

the success of a project and I have mechanisms in place to achieve.

I have expertise in Clinical development of new drugs and medical devices and a

leader in a “Go-No-Go” approach with interaction through other KOL. I practice

GCP/GVP and base work ethics on ICH guidelines. I also have interest in post

marketing compliance for safety monitoring and safety reporting activities (RMPs). I

have also formulated improvisation on some Physician Charts in EMR and software

systems including PACS.

I am experienced in workload management in individual cases safety processing,

aggregate reporting, signal detection and medical review of cases.

End to end experience in global management of safety of marketed drugs. Other

activities are SOP management and strategic planning.

High level of expertise in medical assessment, responding to health authority queries,

provide medical input to aggregate reports, core reference document updates, signal

detection, and all activities pertaining to pharmacovigilance.

As an MBA and Black Belt in Lean six Sigma, I have developed projects within CRO

and other industries to work in achieve desired TAT in shortest possible time with

utmost quality. I am also head of 4DX initiative.

Professional Experience:

April 2011: Staff Radiologist at VirtualScopics, Inc., Rochester, NY. This is a Clinical Trials position in

Radiology in the field of drug and medical device development, research and safety.

1. I have worked on several projects with some of the major pharmaceutical companies on Phase 1-

Phase 1V clinical trials.

2. I follow good clinical practice standards (GCP and GVP).

3. I am certified in pharmacovigilance, pharmacoepidemiology and clinical

monitoring, establishing post marketing surveillance studies.

4. I am well versed with CAPA/ HIPPA.

5. I am an experienced Medical Writer. This requires a consult on the use of imaging

biomarkers with knowledge of the study protocol with knowledge of triage,

validation & ICSR (individual case study reports).

6. I participate in the identification and research of novel imaging biomarkers and their application to

industrial medicine.

7. I have participated in bid defense and charter writing and training of my team.

8. I am experienced in drug safety, Pharmacovigilence, compliance and regulatory process in

GCP/GLP and EU, ICH guidelines with regulatory bodies (FDA 21 CFR Part 820, ISO 13485 and

HSP/BMO) experience.

9. Reporting of adverse drug events (PSUR & PADERs).

10. Knowledge of statistical analysis, population management concepts with knowledge of SAS

programming.

11. Familiar with database (ArisG, AERS etc.)

Clinical Trial Experience

1. Approved Reader with emphasis on Neuroimaging,Cardiology, Oncology,

Pulmonary (expertise in PAH), Musculoskeletal and other Body imaging projects

for multiple major pharmaceutical companies.

2. Tasks and training include Miltiple Sclerosis, Alzheimer’s,Other CNS

projects,RECIST scoring, Cheson scoring, Osteo-Arthritis (OA) scoring,

Quantitative measurement for thigh and calf biomarkers, Rheumatoid Arthritis

(RA) volumetric measures, DCE MRI Perfusion scoring, adjudication, Oncologic

Imaging (all modalities, including PET, PET CT).

3. Medical Device Development.

I do believe that I have:

1.Strong oral and written communication skills.

2. Comfortable and capable of utilizing software programs such as Excel, Word,

and PowerPoint

3. Formal training in Epidemiology and Statistics.

4. Sound organizational skills with the ability to prioritize tasks.

5. Demonstrated project management skills both theoretically and practically

with my formal training as an MBA

Previous Professional Experience:

• March 2011: Associate Professor at All Saints University School of Medicine, Commonwealth of Dominica,

West Indies.

• Jan 2010: Consultant Radiologist & Head of Department at Grenada General Hospital, Grenada. Also worked

as part time Clinical Preceptor at St. George’s University, Grenada.

• August 2008: Visiting Fellow in some esteemed University Medical Centers in USA. I did visiting

Fellowships/Observer ships in MSK, Neuroradiology and PET-CT. PET-CT training was done at Hillman Cancer

Center, University of Pittsburgh Medical Center, Pittsburgh, USA, allowing me unsupervised interpretation of PET-CT

as per American College of Radiology/Society of Nuclear Medicine guidelines.

• Aug 2001-May 2008: Consultant Radiologist &Head of Department in various national and international

Hospitals.

• September 1999: Post-Graduate Resident at J.J.M. Medical College, India and affiliated teaching hospitals in

the Department of Radio-diagnosis.

• July 1997: Kanta Memorial Maternity and General Hospital, Noida, U.P., India.

• May 1994: Full Time Resident in Northern Railway Central Hospital, and D.D.U. Hospital, New Delhi, India

in the department of Medicine and Pediatrics. (A Medical Council of India Recognized Residency Program).

Licenses or Accreditations:

Medical Council of India (Rajasthan Medical Council) - General Registration

Medical Council of India (Rajasthan Medical Council) - Radiologist Registration

(Radiology Board Certification/License from India)

Professional education:

• M.B.B.S. from S.P. Medical College, Bikaner, Rajasthan, India. Completed in 1992.

Housemanship: 1 Year (1993): Medicine3/12, Gen. Surgery 3/12, Obs. & Gynae.

3/12, S.P.M. & Elective Subjects 3/12.

Post –Graduate House-Job Certification from N. Railway Central Hospital, New

Delhi, India. (July 1993 – May 1994)

A Radiology Specialist Diploma-D.M.R.D. from J.J.M Medical College, Davangere,

Karnataka, Rajiv Gandhi University of Health Sciences, Davangere, Karnataka, India.

Completed in 1999.

M.D. in Radiology from University of Seychelles-American Institute of Medicine.

Completed in 2004.

Other Education:

1. MBA in Hospital Administration from Denver.

2. Master Black belt in Lean Six Sigma Methodology from Aveta Business Institute, Ohio.

3. Presently enrolled in Doctorate in Business Administration.

Radiology Workshops/CME

• Attended “Imaging Biomarkers in Clinical Trials: Current Practice and Future Trends” organized by Harvard

Medical School, Boston in 2013

• I attended various Medical device development courses.

• I attended Conference on Radiology Hospital Administrators, Los Angeles, 2013

• I visited the Nuclear Medicine Department (PET-CT) of Weill Cornell Medical College, New York on a

Visiting Professorship in October 2012.

• I attended a Workshop on Advanced Orthopedic and Joint MRI: Emphasis on small joints at Chicago in

November 2011.

• I have Level 4 certification in CT Colonoscopy (Virtual Colonoscopy) from University of Arizona allowing

unsupervised reporting of CTC as per American (AMA) guidelines in 2008.

• I attended a workshop with hands-on training on Virtual /CT Colonoscopy from University of California, San

Francisco (UCSF) in January 2007 under guidance of Dr. Yee Judy, Vice-chair, Department of Radiology, University

of California, San Francisco.

• Visiting Fellowship from University of Pittsburgh Medical Center, Pittsburgh in PET-CT in 2008, allowing

me unsupervised interpretation of PET-CT as per American College of Radiology/Society of Nuclear Medicine

guidelines.

• Observer ship in April 2008 from Georgetown University Medical Center, Washington DC in Breast MRI.

GUMC is a Center of Excellence in Breast Imaging.

Visiting Fellowship in Musculoskeletal CT/MRI and Power Doppler studies from

University of Arizona in 2008.

• Observer ship in 2008 in Neuroradiology (including CT and MR Perfusion studies) from New Presbyterian

Hospital/Weill Medical College of Cornell University, New York.

• Certificate of Completion of educational activity from Institute for Advanced Medical Education, U.S.A. in:

Positron Emission Tomography (PET) scanning in Breast Cancer -Breast MRI

Paper Presentations and National/International Conferences

• Presented a paper at the 12th Annual Congress of Caribbean Society of Radiologist Cruise Conference-

Carnival (June 10th –June 13th) on “MRI in Obstetrics”.

• Attended the 20th International Congress of Radiology held at New Delhi, India on 19th-23rd September 1998.

(This course has been approved by The Royal College of Radiologist for 18Category 1CME credits.)

• Attended various National &State level Congresses on Radiology in India.

• I am a life member of Indian Radiological & Imaging Association, India.

• I am a member of the Caribbean Society of Radiologists.

Other Achievements:

I am a certified Master Black Belt (MBB) in Lean Six Sigma from Aveta Business Institute,

Ohio.

Team Lead in 4DX

Level 2 certification from Radiology Leadership institute, ACR

Languages:

English and Hindi - Reading fluent, Writing fluent, Speaking fluent

Hobbies:

Watching Basketball, football and outdoor activities



Contact this candidate