www.biogensys.com India Hyderabad : Pharmaceutical Drug Safety Analyst

[Admin]

biogensys.com

Biogensys is providing services and staffing solutions to Information Technology, Pharmaceutical, Biotechnology, Medical Device, Contract Research, and Healthcare industries. We provide high quality and cost effective end-to-end solutions to Fortune 1000, mid-sized to small companies.

Drug Safety Analyst
Review of RSGT CIOMS I Target Date report notifying Therapeutic Teams and the CIOMS Manager of cases needing to be expedited. Generating RSGT report of cases with CIOMS I Requirement Status of “Ready” verifying appropriateness of status for each case

Entering bar codes of cases on RSGT report to build a query in ARISg. Generating AEM reports for cases and formatting for attachment to e-mail; Creating a cover letter which includes cases numbers, query dates, regulatory language, initial submission dates for follow-up cases and any necessary informational updates. Submission of report 25, and line-listing to licensing partners. Electronically archiving cover letters, CIOMS I report, listing of serious/related adverse events and Risk/Benefit report.

Archiving hard copy of initial RSGT query, preliminary AEM line listing and regulatory tracking list. Submissions to Regulatory Authorities via the electronic gateway (E2B). Maintance of E2B gateway. Review and resolution of case queries.

JOB REQUIREMENTS:
- 1-2 years pharmaceutical experience desired. Undergraduate degree is required
- A bachelor’s degree in life sciences, nursing or other health-related discipline
- Must be detail oriented, quick learner, good computer skills
- As a contracted member of the Global Distribution & Reporting Group you will work on a team responsible for the review, tracking and Global submissions of Serious Adverse Event Reports
- Strong communication and presentation skills required. Ability to handle multiple tasks simultaneously

Please click here to send a copy of resume.

Regional Office - India
Biogensys India
Begumpet, HYDERABAD - 500 018
Andhra Pradesh, India

http://www.biogensys.com

[Guest]

i want job i do not degree but have 3yrs experienced in Sri Krishan pharamceutcals

[Guest]

i have b.pharma degree2011so i want asuitable job in west up or delhi

[Guest]

Ajeet A Kalegaonkar
E-Mail : ajitakalegaonkar AT gmail.com

Job Objective : To be a life science professional and to explore new avenues and enhance creativity to develop professional ability in Pharma management and develop scientific temperament.
SNAPSHOT
- » MBA (Bio-science Management) completed from School of Bio-Science Management, Pravara Institute of Medical Sciences, Loni Dist.Ahmednagar in July 2010..
- » Gained exposure to various different Bio-science related industries like Wine industry, Dairy industry and Pharmaceutical industries.
- » Excellent communicator with the ability to deal with issues with precision & accuracy.
- » Detail oriented with an analytical bent of mind and positive attitude.

EDUCATION

2010 MBA (Bio-science Management) completed from School of Bio-Science Management, Pravara Institute of Medical Sciences, Loni Dist.Ahmednagar in July 2010 with 63.60%.
2007 B.Pharmacy from Maharashtra college of pharmacy from S.R.T.M. University, Nanded with 63.17%.
2003 HSC from Yogeshwari Mahavidyalaya (Mahashtra HSC Board),
Ambajogai with 58.54%.
2001 SSC from Keshavraj Secondary School (Maharashtra SSC Board), Latur with 57.73%.
TRAINING/ EXPOSURE TO INDUSTRIES
In Fourth Semester (M.B.A. Bioscience)
Project name Process validation studies for Biopharmaceutical like TNK- tPA
Organization Gennova Biopharmaceuticals pvt. Ltd. Pune
Duration 2 month
Role Industrial Trainee
Project scope It is used to determine the critical process parameter or operating variable in sterilization & lyophilization process that influence process
Project Name Industrial training in ‘Quality Assurance & Quality Control’
Organisation Wockhardt Pharmaceutical Pvt. Ltd., Aurangabad.
Duration 1 month
Role Industrial Trainee
Project Scope To get acquainted with documentation procedures of Quality Assurance and Laboratory procedures of Quality Control.
IT SKILLS


- Well-versed with MS Office.
- Well-versed with Windows and internet operations.
EXTRA CARRICULAR ACTIVITIES
- Participated in School level sports competitions like Cricket and chess.
- Participated in School level Debate Competition.

[Guest]

RESUME
Siddartha Dash
Email : siddharth-dash AT live.in
CAREER OBJECTIVE :

To work for a growing organization, which can make best use of my talent, knowledge, dedication, hard work and sincerity by providing me the opportunities to work in different fields to learn different skills and grow as a professional.
ACADEMIC QUALIFICATION :
- Msc clinical research management ( PRIST UNIVERSITY) 2009-2011
- PG Diploma in Pharma Business Management (ICRI) 2010
- B.Pharma (Biju Pattnaik University of Technology, Orissa) 2008
- Intermediate from Anchalik Kishan college,Bargarh,Orissa,2003
- SSC from Rotary Public School,Bargarh,Orissa,2001
PROJECT UNDERTAKEN :
1) Global pharmacovigilance practices : Representation of the Indian scenario
2) Evaluation of wound healing activity of Cissus quadrangularis in excision and incision wound models in experimental rats. (B.Pharma)
WORK EXPERIENCE :
3 months experience in filling up of Case Report Forms in the Post marketing surveillance of Prasusafe (Prasugrel hydrochloride) in patients with acute Myocardial infarction under Dr Nitin Kabra, HOD Department of Cardiology, Gandhi medical college and Hospital, Secunderabad (AP).
AREA OF INTEREST :
Clinical research associate, pharmacovigilance and regulatory affairs
SKILLS :
- Basic understanding of clinical pharmacology and clinical research.
- Ability to work in a group under optimal supervision.
- Sound knowledge on ICH GCP, US FDA and other regulatory requirements.
COMPUTER PROFICIENCY :
- MS OFFICE (Word, excel ,Powerpoint)
- Basic Internet
EXTRACURRICULAR ACTIVITIES
- Represented the college in University annual techno fest at Cuttack.
- Visited production unit of WOCKHARDT in solid & liquid dosage forms
during education tour to Baddi (HP).

[aaron22]

That's really good analyst. This analyst is helps to improve the quality of the medicine. Thanks for sharing this information.

[sahu_ranjita87]

RANJITA SAHU
Email : sahu_ranjita87 AT rediffmail.com

OBJECTIVE :
Seeking for the position of Clinical Research associate to deliver the best of my abilities and self potential, thereby adding to the growth of the organization as well as my knowledge and expertise.
ACADEMIC PROFILE :
Year Course Institute Percentage
2010 - Present PG Diploma in Clinical Trials Management Anna University, Chennai and Apollo Hospitals Education & Research Foundation

2006- 2010 B.P.U.T ,Orissa
(B.pharmacy) Roland Institute Of Pharmaceutical Sciences, Berhampur 8.3 0n 10 scale
2005 CHSE, Orissa (12th) Govt. Junior College, Panposh 72%
2003 HSE, Orissa ( 10th) Fertilizer High School 86%
INDUSTRIAL EXPERIENCE :
Apollo Hospitals Educational & Research Foundation (April 2011- Present)
Clinical Research Coordinator
- Trials in Endocrinology, Dermatology
- Rheumatology
- Cardiology
- Oncology
- Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory and Ethics Committee requirements
- Deep knowledge of monitoring procedures
- Comprehensive knowledge of Apollo Hospitals S.O.P. for conducting Clinical Trials
PROJECT EXPERINCE :
- Project in B.pharmacy
“Study of Anxiolytic and Analgesic activity of aqueous extract of Coriander
seeds in rats” using Photoactometer & Elevated Maze Model.

[Guest]

Sir , I have completed the prescribed requirements for Msc in clinical research from Prist university,Thanjavur.I am eager to know whether there are any job openings for pharmacovigilance or drug safety associate.
I will be grateful to you for your kind intimation.
Thanks and regards
Siddharth Dash

[Guest]

CURRICULUM VITAE
V.Srikanth Reddy
Email ID :srikanthreddy.vudem AT gmail.com

Objective :
- Seeking entry level position in any organization and prove myself.
Educational Qualification :
- B.Sc (Bt.Z.C) from A.V College (OU) with 65% in 2010.
- Intermediate (Bi.P.C) from APRJC with 88% in 2007.
- SSC from Z.P.P.H.S Ainapur (Warangal) with 83% in 2005
Strengths :
- Ability to work in a team.
- Fast learner.
- Ability to learn new things.
·Achievements :
- School Topper in 10th with 83% in 2005.