Pharmacovigilance / Clinical Operation : Resume

[sri.gowri77@yahoo.com]

Curriculum vitae :
T.J.SRI GOWRI
E-mail : sri.gowri77 AT yahoo.com

OBJECTIVE :
To pursue a challenging career in the area of Pharmacovigilance and to become a part of an esteemed organization that gives me scope to enhance my knowledge and skills.

EXPERIENCE :
- 1 yr and 7 months of experience in Clinical Operations.
- Details

Role Company From To :
Project Associate Manipal Acunova Limited, Bangalore 25 Jan 2012 23 Aug 2012
Study Coordinator Yashoda Hospitals, Secunderabad 12 Jan 2011 23 Jan 2012

EDUCATION :
COURSE NAME OF BOARD/UNIVERSITY YEAR OF PASSING PERCENTAGE :
M.Sc in Clinical research Management(Systemic Pharmacology, Clinical research regulations, Clinical Data Management, Pharmacovigilance) ICRI,Hyderabad 2011 82%
B.Sc(Biotechnology, Biochemistry, Chemistry) Osmania University, Hyderabad 2009 75%
Intermediate Board Of Intermediate Education,A.P. 2005 90.5%
SSC CBSE, Hyderabad. 2003 76%

ADDITIONAL QUALIFICATIONS :
- PG Diploma in Pharma Business Management from ICRI (2009-2010)
-Gained knowledge on Human resource management, Finance management, and other managerial aspects

PROJECTS :
Projects carried out in Manipal Acunova Limited
Project 1 :
Title : Investigation of Efficacy and Safety of Linagliptin Co-administered with Metformin QD versus Metformin BID in treatment Naïve patients with T2DM and insufficient Glycaemic control.
Role : Project Associate/Clinical Trial Associate
Description : The project is being carried out to investigate the Efficacy and Safety of Linagliptin Co-administered with Metformin QD versus Metformin BID in treatment Naïve patients with T2DM and insufficient Glycaemic control in a large population.
Through this project, I gained knowledge on the importance of QC of documents at every stage of study, e CTMF, translation process for various documents used in Clinical trial according to SOP, importance of working in accordance with SOPs, importance of tracking the activities and proper Documentation meeting Quality needs in order to face Audits/Inspections.

Projects carried out in Yashoda Hospital, Secunderabad
Project 1 :
Title : Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients with Rheumatoid Arthritis (RA) on Methotrexate treatment but who are not responding.
Role : Study Coordinator
Description : Study was carried out to evaluate the effectiveness of two dosing regimens of Fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking Methotrexate but not responding.
Through this study, I got an opportunity to participate in a Clinical trial as Study coordinator. Carried out the responsibilities of maintaining source documents, updating e CRF and IVRS/IWRS on delegation, IP management, Shipment of collected samples, managing patients visit schedule, coordination between EC and PI, documentation of source documents, lab, EC docs, and correspondence with EC/CRO/Sponsor.

Project 2 :
Title : Comparison of three therapies for the treatment of Non Erosive Reflux Disease
Role : Author/Project Associate
Description : The project is being carried out to compare the efficacy of three therapies in the treatment of NERD.
Through this project, I got an opportunity to design protocol through literature review, design CRF and design the study.

Projects carried out in ICRI
Project 1 :
Title : “An observational study on prevention of Venous Thromboembolism in patients undergoing Elective Total Hip Replacement Surgery”
Role : Observer (in partial fulfillment of PG in Clinical Research Management)
Description : The study was carried out with the objective of determining safety and efficacy of IP when compared to the comparator in prevention of VTE in patients undergoing Elective Total Hip Replacement Surgery.
The IP was proved to be safe and effective in prevention of VTE in patients undergoing Elective Total Hip Replacement Surgery in Phase III.
Through this project, I gained knowledge on new indication, overall role of Study coordinator in the Clinical trial.

Project 2 :
Title : “Case studies review of efficient outsourcing management for maximum savings and proficient services”
Description : The project was carried out with the view to show the importance of efficient outsourcing management.
The efficiency of outsourcing was proven taking 5 case studies as examples.
Through this project, I gained knowledge on choosing the right service provider in terms of cost and quality in order to perform the outsourced task.

TECHNICAL SKILLS :
- M.S.Office applications, Internet application

STRENGTHS :
- Good Knowledge on aspects of Pharmacovigilance, Pharmacovigilance process, safety reporting timelines and Guidelines on Pharmacovigilance.
- Sound Knowledge on ICH GCP and Clinical Research regulatory requirements.
- Ability to grasp quickly, enthusiastic to learn new Professional aspects.
- Good communication and interpersonal skills.
- Good Knowledge on medical terminology.
- Ability to act as a team player.

DECLARATION :
I hereby declare that the above written particulars are true to the best of my knowledge and belief.

Date : 30-11-2012
Place : Hyderabad

T.J.SRI GOWRI

[Guest]

Resume :
ASHA SAMBHAJI JADHAV
Email- ashajadhav89 AT gmail.com

Objective :
To work in a challenging and growth oriented environment, providing ample opportunities for innovation and continuous learning. To repeatedly gain recognition for excellence in work and improvement recommendations. Thus, to help the Organization I work for and thrust towards the future.

Educational Qualification :
College University /Board Year Percentage / Class :
M.Pharm Sem-IV Dr.D.Y.Patil IPSR Pimpri, Pune Pune University 2011-12 66.42%
M.Pharm Sem III Dr.D.Y.Patil IPSR Pimpri,
Pune Pune University 2011-12 “o” Grade
M.Pharm Sem II Dr.D.Y.Patil IPSR Pimpri,
Pune Pune University 2010-11 63.20%
M.Pharm Sem I Dr.D.Y.Patil IPSR Pimpri,
Pune Pune University 2010-11 65.50%
B.PHARM (Final Year) Ashokrao Mane College Of
Pharmacy, Kolhapur Shivaji
University 2008-09 66.15%

Achievements :
- 61st rank at all India level in National Level Pharmacy Talent Search Examination-2008 organized by Cipla Company.

Personal Profile :
Date of Birth 6th April 1989.
Languages Known English, Hindi, Marathi
Marital Status Single
Nationality Indian

Area of Interest :
- Pharmacovigilance
- Drug Regulatory Affairs
- Clinical Trial Operations
- Pharmacovigilance
- Medical coding
- Academics

Publication :
1.Antihistaminic and Bronchodilating activity of fruit berries of EMBELIA RIBES in International Research Journal of Pharmacy.
2.Antiallergic, Antianaphylactic and Mast Cell Stabilizing activity of Pterocarpus marsupium Roxb. International Journal of Research in Pharmaceutical and Biomedical Sciences.
3.Antiallergic and Antianaphylatic activity of Sida rhombifolia Linn in management of Asthma.In International Journal of Advances in Pharmaceutical Research

Co-Curricular Activities :
- Participated in 2 Days state level Workshop on “Intellectual Property Rights” Sponsored by Shivaji University.
- Participated in 2 Days State level Seminar on “Recent Advances in Pharmacological Research” Sponsored by University of Pune.
- Participated in 2 Day National Symposium on “Frontiers in Drug Discovery and Process Research” sponsored by Bharti Vidyapeeth, Kolhapur.
- Participated in state level poster competition, sub-“Role & Scope of Pharmacist in post GMP Scenario in alternative Medicine’s Manufacturing” sponsored by Govindrao Nikam college of Pharmacy, Sawarde, Ratnagiri.
- Participated in workshop on “Generic Product Development & Advances in Formulation & Changing Dynamics of the Pharmaceutical Industry-Expectations from the Future Employees” sponsored by Shivaji University.

Computer Skills :
I had successfully passed the MS-CIT examination with 88%.

Pharmacological Techniques :
- Cannulation of small blood vessels
- Various routes of administration (including i.v, i.p, s.c & oral)
- Blood withdrawal through retro orbital plexus and tail vein
- Isolation of different tissues e.g. ileum, rat aorta, fundus strip, trachea, spleen, liver.
- Knowledge of statistical methods.
- Cell culture technique

Instrument handled :
Biopac Plethysmometer
Histamine chamber Tail flick Analgesiometer
HPTLC UV- Spectrophotometer

Industrial Training :
One month Industrial training in Tahira industries under Piramal Healthcare at Mumbai.
Two month training og Pharmacologist at FORTIS HOSPITAL Mulund, Mumbai.

Project Details :
- “Pharmacological Evaluation of Indigenous Plant for Anti-asthmatic activity.”
In M Pharm.
- “Analysis of Handwritten Prescription on Errors in General Practice” as a part of project work for partial fulfillment of B. Pharm. final Year course under university of Shivaji University. In B Pharm.

Declaration :
I hereby declare that the above mentioned information is true to the best of my knowledge.

Date :
Place :