Medical Reviewer Ahmedabad, Mumbai : Lambda Therapeutic Research

[muthukalee]

Position : Medical Reviewer

Job Purpose :
Medical Review of all cases, aggregate safety reports and to ensure that the reports are completed, error free and in line with the contractual expectation of the client, applicable regulatory requirements, ICH guidelines and company policies.

Key Responsibilities :
* Verify and review all source documents pertaining to a case
* To perform medical review of safety reports, review literature cases and safety data and other pharmacovigilance activities as per the applicable regulatory requirements, ICH guidelines and company policies
* Verify appropriate selection of adverse events; appropriate MedDRA code assignment and accuracy of label assessments for Adverse Events and seriousness criteria of adverse events.
* Responsible for medical review comment, including determination of the company causality assessment, when appropriate.
* Provide drug safety guidance and training.
* Assist with the preparation of relevant training manuals.
* To perform signal detection by detection of early warnings (signals) with regard to previously unknown or unquantified or more severe, previously known adverse drug reactions.
* Medical Review of Aggregate reports like PSURs, PADERs, SBRs, ASRs.

Required Skills and Qualifications :
* MD/MBBS
* 1-5 years or more experience in pharmaceutical industry (clinical research, pharmacovigilance, or medical affairs) preferred.
* Ability to read and interpret AE cases and medical literature, draw conclusions.
* High degree of accuracy and attention to detail.
* Good knowledge / fluency in English (verbal / written). Knowledge of other languages desirable.

Contact us :
Lambda Therapeutic Research Ltd
Near Gujarat High Court
S. G. Highway, Gota
Ahmedabad 380061, Gujarat, India

Mumbai
701, The Great Eastern Summit 'A',
Plot No. 56, Sector 15, CBD/Belapur, Navi Mumbai 400 614, India

careers@lambda-cro.com
http://www.lambda-cro.com

[Guest-IJT]

Name : Dr. sheikh mohd saleem
Email : sheikhmohdsaleem AT yahoo.com
Designation / Skillset : medical officer
i dnt hav any

Resume :
BIO-DATA
Of
DR.SHEIKH MOHD SALEEM

B. Educational Qualification :
Name of Examination Passing Year Marks School/College Board/university
S.S.C 2001 381/500 Tyndale Biscoe School J&K BOSE
H.S.C 2003 441/600 Tyndale Biscoe School J&K BOSE
M.B.B.S 2010,JULY PASS,1132/1500 Jahurul Islam Medical College Dhaka University

CAREER OBJECTIVES
- To make myself grow up through perseverance, hard work and to reflect myself-my optimistic and enthusiastic attitude as well as a vivid imagination-through my work.
- To exercise my initiative, my creativity to its fullest.

ACADEMIC CREDENTIALS
MBBS (Bachelor of Medicine & Bachelor of Surgery) : Completing Year – July,2010
Jahurul Islam Medical College and Hospital,
Bhagalpur, Bajitpur, Kishoregonj.Bangladesh
Higher Secondary Certificate : Completing Year– 2003.
Tyndale Biscoe School,Sheikh Bagh,Srinagar
Board– J&K BOSE.
Subjects : Science
Secondary School Certificate : Completing Year - 2001
Tyndale Biscoe School,Sheikh Bagh,Srinagar
Board– J&K BOSE.
Subjects : Science
..
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More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4272189
Date & Time : 19th Jun 2011 8:51 AM (UTC)
IP Address : 202.56.7.10
Browser Info : Mozilla/5.0 (Windows NT 6.1; rv:2.0.1) Gecko/20100101 Firefox/4.0.1
Predicted Country : Bangladesh

[Guest-IJT]

Name : Iftikhar Haq
Email : drifti2007 AT yahoo.com
Designation / Skillset : Dermatologist
I am aqualified dermatologist from Pakistan having 40 years experience in various hospitals presently living in USA

Resume :

EMPLOYMENT HISTORY
Worker, Hendrix Batting, High Point, NC 27263 12/2007 -08/2010
Dermatologist, Instructor, in-charge pharmacy Alghazi Hospital, Hari Pur NWFP, Pakistan, 09/1996 – 02/2007
Medical Officer in-charge, instructor, in-charge pharmacy Faugi Foundation, RWP, Pakistan 08/1991 - 08/1996
Medical Officer In-Charge Psychiatry Department, Dermatologist, instructor
Karachi Hospitals Limited, Karachi, Pakistan 02/1979 – 07/1991
Medical Officer, Dermatologist, instructor Pakistan Army 11/1969 – 01/1979

Description of Medical Experience :
Check and diagnose patients.Advise and prescribe treatment and medicines for patients.Teach and give advice to the patients for their diseases. Admit and treat the serious patients in the hospital. Teach the staff about the diseases and patient care. Advise the required investigations in laboratory. Perform minor surgical procedures in dermatology. Research in dermatological diseases and their treatment.

EDUCATION
Diploma In Dermatology, Armed Forces Postgraduate Medical Institute, RWP, Pakistan 09/1973
MBBS (bachelor in medicine & surgery), Khyber Medical College Peshawar, Pakistan, 09/1969
F S C Government Degree college Rawalpindi Pakistan 08/1964
High school diploma G H S Ghazi Pakistan 09/1962

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More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4270938
Date & Time : 18th Jun 2011 7:20 PM (UTC)
IP Address : 216.237.225.194
Browser Info : Mozilla/4.0 (compatible; MSIE 8.0; Windows NT 6.1; WOW64; Trident/4.0; SLCC2; .NET CLR 2.0.50727; .NET CLR 3.5.30729; .NET CLR 3.0.30729; Media Center PC 6.0)
Predicted Country []: United States

[Guest]

CURRICULAM-VITAE
SEJAL PATEL
E-MAIL : sejupats15 AT gmail.com
OBJECTIVES :
Seeking a position to utilize my skills and abilities in the pharmaceutical Industry that offers security and Professional growth while being resourceful, innovative and flexible.
PERSONAL SKILLS :
Ability to withstand all my failures and to deal people diplomatically, willingness to learn, Team Facilitator.
EDUCATIONAL QUALIFICATIONS :
S.NO
NAME OF
EXAMINATION YEAR OF PASSING AGGREGATE
COLLEGE / UNIVERSITY
1.
B.Pharma
2007
71%
APMC College
Himatnagar
North Gujarat University
2.
D.Pharma.
2004
71%
L M College
Ahmedabad
Gujarat university
3.
Higher Secondary Examinations.
2002
72%
G.S.E.B.
4.
Senior Secondary Examinations.
2000
88.57%
G.S.E.B.
- AREA OF INTEREST : R&D,F&D,QA,CLINICAL RESEARCH
- WORK EXPERIENCE AT FISHER BIOPHARMA SERVICES
Worked as a Team Leader, Packaging in Fisher BioPharma Services (India) Pvt. Ltd., Ahmedabad- from 31th May, 2010 to 15th November 2010.
JOB RESPONSIBILITIES AT FISHER BIOPHARMA SERVICES (INDIA) PVT. Ltd.
- Manpower planning and handling.
- Clinical packaging operations in Secondary Packaging.
- Qualification and Preventive Maintenance of machines in Packaging department.
- Up gradation and preparation of SOPs.
- Performed the training of Assistant packaging and Operators.
- Preparing and updating the Training Tracker, Training Matrix and Training Plan for the Assistant Packaging, Operators and Team leaders.
- Performed the IQ, OQ and PQ of Walleting and Shuttle machine and handling the process.
- Updating and Reviewing the Training Files of the Operators and Assistant packaging.
PREVIOUS EXPERIENCE :
Worked as a junior pharmacist at U.N.Mehta Institute of Cardiology, Civil, Ahmedabad from 25th Nov, 2008 to 23rd May, 2010.
JOB RESPONSIBILITIES AT U. N. MEHTA INSTITUTE :
- Dispensing of medicines and surgical items.
- Co-ordination with surgeons and paramedical in surgery.
- Handling and maintaining of medicines.
- Planning and maintaining data of the pre and post operative patients.
INDUSTRIAL TRAINING :
Saarthi pharmaceutical, Santej, Ahmedabad
COMPUTER SKILLS :

o MS Office 2007
o Internet usage