www.lotuslabs.com Lotus Labs Pvt Ltd Bangalore : Clinical Investigator

[STSRekha]

Company Name : Lotus Labs Pvt Ltd
lotuslabs.com
Location : Bangalore
Designation : Clinical Investigator

Lotus Labs has a rich legacy in nurturing leadership in all facets of activity – exemplified by the significance that we accord to team building and encouraging innovation. In line with current and long-term growth plans, we are expanding our team, and encourage individuals who share the passion for innovation and the zeal to excel, to join the team

Clinical Investigator
Post Name : Clinical Investigator
Location : Bangalore
Relevant Exp : Experience in Dermatology practices (Diploma/equivalent training).
Key Exp : Interested in clinical Trial
Qualification : MBBS

About us :
Lotus Labs is a Clinical Research Organization with extensive experience in conducting Clinical Trials in healthy volunteers, patient populations and special populations. With the nerve centre at Bangalore, India, Lotus Labs offers an extensive portfolio of services – spanning Phase I to III studies – for global pharmaceutical and biotechnology companies. With a battery of services, from end-to-end Clinical Trials to stand alone services, Lotus Labs has an impressive track record with expertise across all facets of Clinical Research, powered by proficiency in the areas of Bio Studies, Clinical Trials, Bioanalytical Research, Biometrics, Medical Writing and Regulatory Services.

Contact us :
Lotus Labs Pvt Ltd.
Lotus House
# 07, Jasma Bhavan Road
Millers Tank Bed Area
Opp. Guru Nanak Bhavan
Vasanth Nagar
Bangalore - 560 052

Website : http://www.lotuslabs.com

[Guest]

DR. PUSHPA VENKATARAMAN

M.B.B.S, PDCR


Medical Professional with experience in clinical field and pharmaceutical industry .
OBJECTIVES –
Timely completion of the allocated responsibilities and providing quality work.
Expertise in preparation of CTD modules, Safety Reports, Package inserts and SmPCs.
Providing inputs for identifying new products as per the market requirements.
QUALIFICATION -
M.B.B.S. with 11.6 years of experience, with 4.6 years experience in pharmaceutical industry and 7 years of clinical experience.
Professional Diploma in Clinical Research (PDCR) from Catalyst Clinical Services, New Delhi.
Post Graduate Program in Pharmacovigilance from Cliniminds, New Delhi.
EDUCATIONAL CREDENTIALS :
DEGREE YEAR OF PASSING INSTITUTION UNIVERSITY
SSC 1991 CBSE CBSE BOARD NAGPUR UNIVERSITY
HSC 1993 HSC SHRI SHIVAJI SCIENCE
COLLEGE NAGPUR
M.B.B.S April / May 1999 NKP SALVE INSTITUTE OF NAGPUR UNIVERSITY,
MEDICAL SCIENCES & RESEARCH CENTRE
PDCR March 2009 CATALYST CLINICAL SERVICES , NEW DELHI -
Post Graduate Program January 2010 CLINIMINDS, NEW DELHI
in Pharmacovigilance

PERIOD OF INTERNSHIP : 01/07/99 to 30/06/2000
MMC REGISTRATION NO. : 2000 / 08 / 2762

MMC RE- REGISTRATION NO : MMC/Renew/2006-07/17276
MCI REGISTRATION NO. : 201(34)2001-Reg./30148
IMR REGISTRATION : 201(34)2006 –IMR / 11437


CAREER GRAPH :
CURRENT JOB PROFILE
ASSISTANT MANAGER IN MEDICAL AFFAIRS DEPT .
Presently employed as Assistant Manager in Medical Affairs dept. at Promed Exports Pvt . Ltd. a pharmaceutical company located at Gurgaon, Haryana engaged in the production of ophthalmic products, injectables and tablets.
JOB RESPONSIBILITIES :
Preparation of Standard Operating Procedure related to various activities carried out by the Medical Affairs dept. like conduct of BA/BE studies , clinical trials and preparation
of modules.
Preparation of module 2, 4 and 5 for the purpose of registration and re-registration of various products in Russia and other CIS countries.
Preparation of module 2, 4 and 5 for the purpose of registration and re-registration of various products registration in regulated market.
Effective preparation and updating of Periodic Safety Update Reports of various products as per guidelines.
Effective preparation of Package Inserts for Russia and other CIS countries, EU and US markets.
Effective preparation of Summary of product characteristics.
Ethical conduct of Bioequivalence studies as per ICH and GCP guidelines.
Preparation and compilation of comparative data and market product analogues for various products as & when required.
Handling various medical queries from other departments.

PREVIOUS JOB EXPERIENCE
1. AS MEDICAL OFFICER
Medical Officer at Global Hospital & Research, Mount Abu (Rajasthan) for 2 years from August 2000 – August 2002.
Responsible for
Independent shift duties in ICU/CCU.
Critical medical and surgical cases patients requiring intensive care treatment and on life support systems.
ICU procedures and handling of various complicated instruments.

2. AS RESIDENT DOCTOR
Resident Doctor at Ekvira Heart Institute, Nagpur, Maharashtra for 6 months from Jan 2003 to June 2003 in CCU/MICU.
Duties -
Independent management of critical cardiac cases requiring intensive care monitoring and treatment.
Handling post angiography, post angioplasty and post cardiac surgery patients.
3. AS MEDICAL OFFICER
Medical Officer at Apollo Victor Hospital, Margoa, Goa from August 2003 to August 2005.
ICCU / CCU POSTING
Responsibilities Handled -
Critically ill patients (Medical/Surgical), requiring strict intensive care monitoring and treatment.
Post angiography, post angioplasty and post cardiac surgery patients in CTVS-ICU.
EMERGENCY ROOM/CASUALTY -
Responsibilities Handled –
Serious medical / surgical cases
Trauma cases
ER procedures
Emergency calls in ER. Escorting patients from home/other hospitals to Apollo Victor Hospital in the ambulance accompanied by adequate medical staff.
articipated in a medical coverage provided by Apollo Victor Hospital at the International Film Festival venue at Panjim, Goa. Handled various OPD cases and other cases at the venue during the event.
4. PRINCIPAL MEDICAL INVESTIGATOR
Principal Medical Investigator at CLL CLIN BIOS, a Central Research Organisation(CRO), located at Vapi, Gujarat, from Sept. 2005 to Jan. 2007
JOB PROFILE :

Setting up the Clinical Research Unit (CRU).
Setting up of Intensive Monitoring Unit
Preparation of clinical Standard Operating Procedures and other essential documentation.
Preparation of various equipment related Standard Operating Procedures.
Ensuring efficient and ethical conduct of BA/ BE studies as per ICH – GCP guidelines
Ensuring efficient and ethical conduct of clinical trials as per ICH – GCP guidelines.
Screening of volunteers (based on clinical examination and laboratory values) .
Recruitment of volunteers as per Inclusion / Exclusion criteria & management.

Conducting Stress Tests, Spirometry, Resting ECG.
Gained knowledge of clinico-pharma regulatory affairs – ICH, FDA, Good Clinical Practice( GCP) , Schedule Y and Pharmacovigilance.
Monitoring and treating sudden unexpected ADR’S in volunteers/ subjects.
Providing training to the clinical monitors and the clinical research assistants for ensuring smooth conduct of trials and studies.

PARTICIPATION IN CLINICAL WORKSHOPS & SEMINARS
1.Trained in BASIC LIFE SUPPORT (BLS) & ADVANCED CARDIAC LIFE SUPPORT (ACLS) conducted by American Heart Association (AHA).
2.Attended conference & workshop on PHARMACOVIGILANCE and ADR MONITORING at Ahmedabad in Nov. 2005.
3.Attended a workshop on MEDICAL AND SCIENTIFIC CONTENT WRITING at New Delhi in April 2009.
COMPUTER EFFICIENCY : Trained in -
MS Word
MS Excel
MS Wordpad
Open Office
Internet Browsing
Basic computer knowledge

PRESENT CTC : 8 lakhs per annum
PERKS : Yearly Performance based bonus.
Medical Insurance
Reimbursement of medical bills
Yearly LTA
EXPECTED CTC : Higher package
PREFERRED LOCATION : ANYWHERE IN SOUTHERN, NOTHERN & WESTERN INDIA.
RELOCATION : Yes
REASON FOR RELOCATION;: For seeking better opportunity.

[Guest]

PARTHASARATHI T. R.
Parthu_14 AT yahoo.co.in

Career Objective :
- I am in the pursuit of acquiring all the competencies for a satisfying career and always willing to face new challenges and critical tasks, which offer potential growth and development through the spirit of teamwork.
Organizational Experience :
- From Mar-2006 to Jan 2007 with Micro labs Ltd., as “Research Associate”, in analytical R&D department.
- From Jan-2007 to Apr 2011 with Suven Life Sciences Ltd., as “Research Associate”, in Bioanalytical department.
- From May 2011 to till date as “Assistant Manager-BIOANALYTICAL”, in Bioanalytical department at Quest life sciences Chennai.
Summary of skills & experience :
- 51/2 years of experience in the field of Bioanalytical using HPLC and LC-MS/MS in Bioequivalence and Bioavailability studies.
- Sound knowledge of GLP techniques.
- Rich experience of developing and validating Bioanalytical methods as per FDA, ANVISA, EMA guidelines.
Instrument exposure :
- LC-MS/MS – MDS SCIEX (API 2000, 3000, & API 4000)
- HPLC – Shimadzu, Perkin Elmer, Agilent 1200 & Agilent 1100, Waters Alliance 2695
- SOFTWARE – Analyst versions 1.4, 1.4.1, 1.4.2 (MDS SCIEX)
- Thermo TSQ QUANTUM LC-MS/MS system - LC Quan SOFTWARE- version 2.5.6 (Thermo TSQ quantum)
Job Responsibility :
- Method development & Method Validation by using various extraction procedures like liquid – liquid extraction, solid phase extraction and precipitation and analysis by LC-MS/MS (MDS SCIEX : API 3000, API 4000, Thermo TSQ QUANTUM) as per current FDA guidelines.
- Analysis of Clinical samples using Liquid – Liquid, Protein precipitation and Solid Phase Extraction Techniques with LC – MS/MS (MDS SCIEX : API – 3000, API – 4000) and HPLC as per GLP requirements.
- Responsible for the development of simple, robust, cost effective, Analytical Methods for Drug/Metabolites using LC – MS/MS, HPLC Techniques in Biological matrices.
- Review of Method SOP’S and Laboratory SOP’S as per the need.
- Review of method validation and analytical reports.
- Development and maintaining many successful efforts for GLP compliance in Bio-analytical laboratory.
- Documentation procedures as per departmental standard operating procedures (SOPs) and regulatory guidelines.
Achievements :
- Method development and validation for : Sibutramine, Haloperidol, Melperone, raclopride, Sitagliptin, Felodipine, aspirin and salicylic acid, sarpogrelate Simultaneous estimation for various NCE’s.
- BE studies for Trandolapril, Aspirin & Salicylic acid, Fluvastatin, Enalapril, Atorvastatin and metabolites , Fexofenadine, Diclofenac sodium, cetrizine, olanzepine, Loratadine&Desloratadine, Sirolimus, Everolimus, Furosemide. Levocetrizine, Tolterodine&metabolite, Tramadol, Carvedilol and metabolite, Zolpidem, Lepatinib, Montelukast, propranalol, Tacrolimus, Montelukast
- Invivo brain distribution studies of various NCE’s.
Educational Qualification :
- Maters in Pharmacy in “Pharmaceutical Analysis” from Dr. MGR Medical University, Chennai in 2006.
- Bachelors in Pharmacy from Dr. MGR Medical University, Chennai in 2002.
Papers published & presented :
- Liquid chromatography tandem mass spectrometry method for the quantification of sarpogrelate, a selective 5HT2A receptor antagonist in plasma : application to preclinical pharmacokinetic study – paper published in journal – Biomedical chromatography
- Simultaneous extraction of acetyl salicylic acid and salicylic acid from human plasma and simultaneous estimation by liquid chromatography and atmospheric pressure chemical ionization/ tandem mass spectrometry detection – paper published in Arzneimittel forschung (Drug research)
- Analytical method development and validation of ciprofloxacin and ornidazole in tablet dosage form by RP-HPLC Method. (57th Indian Pharmaceutical congress, Hyderabad-poster presentation)
- Analytical method development and validation of Levofloxacin and ornidazole in tablet dosage form by RP-HPLC Method. (61st Indian Pharmaceutical congress,Ahmedabad-poster presentation)
- Simultaneous determination of aspirin, clopidogrel bisulphate and atorvastatin calcium in capsule dosage form by RP-HPLC. (3rd World congress on Bioavailability & Bioequivalence- poster presentation)
Audits faced :
- NABL audit three times while working in suven life sciences Ltd.
- More than 20 client audits while working in suven life sciences Ltd.
- 15 client audits in Quest life sciences pvt Ltd.
- FDA audit on clinical study of Exemestane, Temozolamide