Resume CV : CRA & Regulatory affairs

[umesh sonje]

CURRICULUM VITAE :
UMESH BALIRAM SONJE.
E-mail : umanshu09 AT gmail.com

Objective :
To seek a scientific position that would enable to utilize my expertise and provide growth opportunities.

Professional Synopsis :
ICH-GCP Pharmacovigilance. (A.D.R., A.E., S.A.E., A.D.R Reporting, A.D.R. Reporting Guidelines)
B.A., B.E. Studies Clinical Data Management C.R.F. & Protocol Designing

Academic Credentials :
Post graduation : M.Sc. Pharmaceutical Medicine. 2nd year (scholar)
(Seth.G.S.M.C & K.E.M Hospital, Mumbai.& MUHS. Nasik. )
Graduation : B.Pharm. (R.D.C.O.P.Bhor.Pune.) – 59.58%
Under-Graduation : Maharashtra State Board of Secondary & Higher Secondary Education (N.D.M.V.P.Samaj’s College, Nasik.) – 60.50%

Areas of Interest :
Pharmacovigilance & Clinical Data Monitoring
Clinical Research Associate
Medical writing
Regulatory affaires

Work Experience :
Worked as Clinical Business Associate in Unichem Lab.Ltd. Jogeshwari(w),
Mumbai with extensive experience in pharmaceutical marketing for 14month
(June2007-Aug2008)

Presently working as Manager Marketing with Yashda Medicare,Hanumanwadi, Panchavati,Nasik. From last 13months.
Professional Registration :
Registered Pharmacist in Maharashtra State Pharmacy Council, Mumbai, India and entitled to receive all the Privileges granted under the Indian Pharmacy act 1948. Registration/Certificate no.–99720

Research Study :
Worked on Msc(Pharmaceutical Medicine.) Research Project entitled ‘’Prospective observational study on Pros asnd Cons of Fixed Dose Combination on Antihypertensive Therapy.’’ Under the guidance of Dr.Dhananjay Sangle.MD (Paed.) & Dr.Amit Naik.MD (Gyn). University Department of Interpathy Research & Technology (UDIRT),MUHS.Nashik.

Projects ongoing :
‘’ Prospective study to evaluate the use of alternative medicinessss(complementary) in chronic diseases.’’ Under the guidance of Professor and Head of Department Of Clinical Pharmacology, Dr. U. M. Thatte.( M.D., D.N.B., PhD, FAMS.) & Dr. Nithya Gogtay. M.D. D.N.B.(Pharmaco)D.N.B.(Clinical Pharmac). Seth G.S Medical College & KEM Hospital Parel, Mumbai.

“Usefulness of Likert scale & Guttman scale for measurement of attitude of health care professionals in India towards adverse drug reactions (ADRs)
reporting : Interdisciplinary approach” Under the guidance of Lecturer, Mr.Avinash Khairnar. MPharm(Pharmac),MBA(HRM). UDIRT,MUHS.Nashik.
Prescription monitoring in ‘Acute (Monsoon Related) Fever in Adults’ by MUHS, Mumbai, 2009.
Pharmacovigilance Activity, K.E.M.Hospital, Mumbai, 2009.
Therapeutic drug monitoring. K.E.M.Hospital, Mumbai, 2009.

Working as Internal Monitor on IPCA trial for malaria. K.E.M.Hospital, Mumbai, 2009-2010.
Conference,Workshop,Seminars attended :
Participated in Three days National Workshop on “Recent Advances and Future Scenario in Preclinical & Clinical Pharmacology”; September 2008; Organized by SGRS College Of Pharmacy, Saswad.
Participated in “60th Indian Pharmaceutical Congress”, 2008, Themed “Pharma Vision 2020 : Regulations for Better Healthcare”, at NSIT, New Delhi; Indian Pharmaceutical Congress Association (IPCA), during 12th – 14th December, 2008.
Participated in’’Seminar and workshop on research methodology for Ayurvedic, Unani and Homoeopathy post graduate students’’ as Member registration committee and Speaker at protocol design hands on table, March 2008.
Participated3rd International Annual Conference on ‘‘Drug discovery & development-Challenges in partnership’’ South Asian Chapter of American College of Clinical Pharmacology. Oct.2009, Mumbai.

Achivements :
Awarded,‘’RAJYAPAL PURASKAR’’ in NCC-SCOUT by Hon. GOVERNER of Maharashtra. in 1999.
Qualified GATE Exam with AIR 4001 and Score 287 conducted by IIT, Kanpur in March, 2007.
Qualified Entrance exam with AIR 32 & 29 for M.Tech conducted by VIT, Vellore, Tamilnadu in May,2007 & 2008.
Secured 11th rank in Entrance exam for MSc(Pharmaceutical Medicine) conducted by Maharashtra University of Health Science(MUHS). Nashik. Maharashtra.

Computer Exposure :
Packages : MS Office, MS DOS etc.
Operating System : Windows- 98, 2000, XP and latest versions
Concepts : Computer Fundamentals and Information Technology.

Personal skills :
Comprehensive problem solving abilities,
Ability to deal with people diplomatically,
Willingness to learn team facilitator and hard working.
Willing to travel

Personal Detail :
- Date of Birth : 9th March 1984.
- Age : 25year.
- Sex : Male.
- Marital status : Single.
- Languages known : English, Hindi, Marathi.

Declaration :
I hereby declare that all the information given above is true to my knowledge.

Date :
Place :

Yours Faithfully,
UMESH B. SONJE.

Subject studied during M.Sc. in Pharmaceutical Medicine (UGC & MCI Granted) :
As this is the only third batch of students coming out with knowledge of such study course (M. Sc. Pharmaceutical Medicine), I would like to highlight some key subjects which we have studied, which you might find of mutual benefit and interest, more specific details can be discussed during interview.

First Year :
- Discovery of New Medicines
- Pharmaceutical Developments
- Toxicity Testing
- Legal & Ethical issues in clinical Research
- Clinical Trials
- Statistics & Data management
- Pharmacovigilance.
- Economics of Health Care
- Basic concepts in Allopathic Medicine
- Development of Drug From Herbal Source & Standardization
- Analytical Methods, QC/QA, Advances in Technology of drug development

Second Year :
- Safety of Medicines
- Regulatory Affairs
- Information, Promotion & Education
- Economics of Health Care
- Medical Departments
- Development of Medicines
- New drug delivery system(NDDS)
- Genomics, Biotechnology, Nanotechnology & Bioinformatics
hya Gogta

[Guest]

CURRICULUM VITAE :
Mustansir Dudhwala
E-mail :mustansirdudhwala52 AT yahoo.in

Education :
B.pharm Dharamsinh Desai Institute D.D.University 2009-2012 60%( III)
D.Pharm M.N College of pharmacy Gujarat University 2007-2009 64%
HSC M.K higher secondary Gujarat Board 2007 68% School(GLS)
SSC M.K higher secondary Gujarat Board 2005 72%School(GLS)

Experience :
Company : Trainee at stenmark pharmaceuticals
Duration : 6 Months
Profile : Quality Control
Place : Ahmedabad

Computer Skills :
Operating Systems : Windows, DOS, XP, VISTA
Packages Known : MS Office (Word, PowerPoint, Excel)

Extra Curricular Activities :
- Participated in International conference on Nano suspension.
- Participated in workshop at Parul Institute of pharmacy

Hobbies :
Listening to music and playing cricket

Strengths :
- Good in team work
- Passionate & Dedicated towards my work
- Ability to adapt changing environment.
- Self motivated