Biogensys India Hyderabad : pharmaceutical Drug Safety Analyst

[Admin]

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

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

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[kakkadkeyurg]

KAKKAD KEYUR G.
M. pharm (Pharmacology)
Contact No: +919742171734(M)
E-mail: keyurkakkad9 AT gmail.com
keyur_rx_kk AT yahoo.co.in

Career Objective:

To work in stimulating and challenging environment, and to explore potential within by applying my technical skills and knowledge which can be best utilized for development of an organization.

Technical Skills:

* Handling of animals: Rats, Mice, Rabbits and Guinea pig
* Blood collection: Retro orbital puncture.
* Cannulation: Carotid artery and Jugular vein.
* Administration of drugs: Oral, intraperitoneal (i.p.).
* Isolated tissue experiments: Ileum, jejunum, uterus and fundus.
* Langendroff’s isolated heart preparation.


Equipments handled:

* UV spectrophotometer (Shimadzu, Jasco)
* Student’s physiograph (INCO)
* Langendroff’s isolated mammalian heart set up

Other Skills:

·Strong interpersonal skills including ability to work in a large team.
·Having a good communication skill and can adjust in any working environment.
·Time management
·Ability to apply pharmacology knowledge in practical field with innovative idea.

Computer knowledge:

·MS office (MS word, Excel, Power point)
·Internet browsing

Area of interest:

* Pre-Clinical studies
* Research and Development.
* Clinical research
* Pharmacovigilance


Project Work:

M. Pharm:

Evaluation of TRANQUIL a, Polyherbal Proprietary Medicine for Anxiolytic Potential in Exteroceptive Behavioural models.(Stair case test, Novelty suppressed feeding behavior, Light and dark exploration model & Locomotor activity).


Industrial Training:

·Twenty one days industrial training in different sections including production, Quality control and Quality Assurance department at Sparsh biotech Private Limited Lakhabavad Jamnagar-361006.

·Industrial visit in all sections of Remidex private limited Bangalore.

Achievements:

·Poster presentation at the Annual conference of south regional Indian Pharmacological Society Sponsored by Indian council of medical research, New Delhi. Topic- Evaluation of a Tranquil- a polyherbal Formulation for Anxiolytic effects in Animal models.
·Poster presentation at the Annual conference of south regional Indian Pharmacological Society Sponsored by Indian council of medical research, New Delhi. Topic- Evaluation of a STP. a polyherbal Formulation for Antidepressant effect in Animal models.
·Actively participated in 2nd Annual Convention of Association of Biotechnology and Pharmacy &National Seminar on Pharmacogenomics and its Application in Drug Discovery.
·Actively participated in national level conference on BIOTECHNOLOGY AND IPR, held at P.E.S College of pharmacy Bangalore.
·Actively participated in seminar on “Clinical research – Advances and Opportunities” at Bangalore, February 2008.
·Achieved third rank in the Department of Pharmacology in first year M.Pharm and secured Distinction.

Extra activities:

·Passed ‘A’ Certificate examination under the authority of Ministry of Defence, Government of India.(National cadet corps.)(N.C.C).
·Actively participated & got first prize in national level dance compition.
·Actively participated & got prizes in sports.

Personal Detail:
NAME: Kakkad Keyur Girdharbhai.
D.O.B.: 18th march, 1986
FATHER NAME: Shri Girdharbhai Vrajlal Kakkad.
MOTHER NAME: Smt. Sadhanaben Girdharbhai Kakkad.
LANGUAGE KNOWN: Hindi, English, Gujarati
NATIONALITY: Indian
HOBIES: Dancing, Computer work, Reading& Music

Declaration:
I hereby declare that all the information mentioned here is true to the best of my knowledge and I will personally be held liable if facts found misrepresenting.

DATE
SIGNATURE

[sushmitha07]

CURRICULUM VITAE
Sushmitha.M

CARRIER OBJECTIVE:-
Seeking a challenging career where my skill set and synergy can be put to maximum use for mutual growth of the organization and myself working in diversified fields

EDUCATION QUALIFICATION:-
Examination School/college Board/ university Year of passing Marks (%)
B.Pharmacy R.R.College of Pharmacy Bangalore. Rajiv Gandhi University of Health Sciences Bangalore. 2009 75
Intermediate Narayana Jr. College Kurnool. Board of Intermediate
Education 2004 75 S.S.C Visveswarayya Memorial High School Gadwal Board of Secondary Education 2002 78

B.Pharm Final Year Project Details:
Training : Undergone industrial training
Duration : 2 months
Department : Production, stability.
Company : Dr.REDDY’S LABOURATORY,FTO II , BACHUPALLI ,
HYDERABAD.
Guide : Ch. Pavan Kumar
Senior executive, Dr.Reddy’s lab’s,
F T O II, bachupalli,Hyd.

Equipments handled:

- Tablet punching machine
- Capsule filling machine
- UV spectrophotometer
- Agilent HPLC 1100
- Pampas liquid particulate matter analyzer
- Brooke field Viscometer
- FTIR

Seminars Given :
1. Clinical research opportunities.
2. hospital formulary project.

Technical skill sets :
Diplama in computer Applications , hands on experience on computers, mainly with MS Office (MS Word and Power Point)
Suitability for your organization:

- Focused proactive Approach
- Good Communication Skills
- Punctuality
- Team Work
- Belief in self
- Confidence
- Positive Approach

Place:Gadwal
Date: 26-12-2009
(SUSHMITHA.M)

[Careers]

CURRICULUM VITAE
Navakanth. B Mail: bnavakanth AT gmail.com
Mobile: 09490213573

Objective:
Focus on a challenging career in an industry seeking a quality environment where my knowledge can be shared and enriched looking for the opportunity where I can improve my skills.

Personal Skills: Comprehensive problem solving abilities, Ability to deal with people diplomatically, willingness to learn, Team facilitator.

Area of interest:
Bioavailability & Bioequivalence
Pharmacovigilence
Clinical Research (Associate/Auditor/Coordinator)


Education Summary:

S.No COURSE
INSTITUTION YEAR %OF MARKS

1.
M. PHARMACY (Pharmacology) Annamalai university,

Chidambaram.
2007-2009
7.8 CREDIT POINTS

2.
B.PHARMACY R.I.P.E.R.
ANANTHPUR,
J.N.T.U., HYDERABAD.
2003-2007
70 %

3.
INTERMEDIATE
Goutham jr. college,
vijayawada
2001-2003
81 %
4. S.S.C Bhashyam public school,
Guntur. 2000-2001 87.5 %


Present status:
Working as a Assistant Professor in MITS college of pharmacy, kodada from July 2009 to till date
Academic project:
Project: Assessment of safety and efficacy of fixed dose combination of Glimeperide and Metformin in patients with type 2 diabetes mellitus.
Duration: 8 months.
Role: Trainee Clinical Research Coordinator
Organization: Mediciti Hospital, Hyderabad.

Responsibilities:

- Perform enrollment, screening, randomization and close-out activities.

- Telephonic visit and record of the same.

- Communicate with the sites on administrative matters.

- Report patient status at site to principal investigator / Project Manager.

- Review patient related logs, forms and report in-house.

- Track protocol deviations, adverse events and study material at sites.

- Serious adverse event reporting & record of the same.

- Maintain documents related to the sites in-house.

- Perform administrative duties including attendance at clinical monitoring staff meetings, project team meetings and clinical training sessions.

Software Skills:
Operating Systems : MS-DOS, Windows 95/98.
Office Tools : MS-Office 2007, MS-Excel 2007.


Conferences attended:
- Attended Indian pharmaceutical Congress (IPC) Programme held in Hyderabad
- Attended a National conference on ANIMALS WELFARE & ETHICS held in ANNAMALAI UNIVERSITY, CHIDAMBARAM.
References:
Dr. Naveen Chander Reddy M.D Dr. V. Parthasarathy M.Pharm. PhD,
Cardiologist & Clinical research Co-ordinator, Professor,
5-9-22, Mediciti Hospitals, Department of pharmacy,
Secretariat Road, Annamalai University,
Hyderabad-500063. Tamilnadu.

Personal Profile:
Name : B.NAVAKANTH
Father’s Name : B.SAMBASIVA RAO
Date of Birth : 05-05-1986
Sex : Male
Marital Status : Single
Nationality : Indian
Address : S/o sambasiva Rao
Attaluru (v)
Amaravathi (m)
Guntur (D)
Andhra pradesh-522436
Languages Known : English, Hindi and Telugu

Declaration:

I here by declare that the information furnished above is true to the best of my knowledge

Yours Sincerely,
B.NAVAKANTH

[sushmitha07]

CURRICULUM VITAE

CARRIER OBJECTIVE:-
Seeking a challenging career where my skill set and synergy can be put to maximum use for mutual growth of the organization and myself working in diversified fields

EDUCATION QUALIFICATION:-

Examination School/college Board/
university Year of
passing Marks (%)
B.Pharmacy R.R.College of Pharmacy Bangalore. Rajiv Gandhi University of Health Sciences Bangalore. 2009 75%
Intermediate Narayana Jr. College Kurnool. Board of Intermediate
Education 2004 75%
S.S.C Visveswarayya Memorial High School Gadwal Board of Secondary Education 2002 78%


B.Pharm Final Year Project Details:
Training : Undergone industrial training
Duration : 2 months
Department : Production, stability.
Company : Dr.REDDY’S LABOURATORY,FTO II , BACHUPALLI ,
HYDERABAD.
Guide : Ch. Pavan Kumar
Senior executive, Dr.Reddy’s lab’s,
F T O II, bachupalli,Hyd.

Equipments handled:

- Tablet punching machine
- Capsule filling machine
- UV spectrophotometer
- Agilent HPLC 1100
- Pampas liquid particulate matter analyzer
- Brooke field Viscometer
- FTIR

Seminars Given :
1. Clinical research opportunities.
2. hospital formulary project.

Technical skill sets :
Diplama in computer Applications , hands on experience on computers, mainly with MS Office (MS Word and Power Point)
Suitability for your organization:

- Focused proactive Approach
- Good Communication Skills
- Punctuality
- Team Work
- Belief in self
- Confidence
- Positive Approach

Place:Gadwal
Date: 11-12-2009
(SUSHMITHA.M)