Pharmacovigilance Officer/Drug safety Physician : Hyderabad

[pharmacovigilance]

Designation: Pharmacovigilance Executive/Physician
Experience: 3 - 5 Years
Location:Hyderabad
Education: MBBS - Any Specialization
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Posted Date: 21 Sep

Responsibilities:
** To provide Medical Information to internal and external enquirers.
** To record all details of Medical Information queries in an accurate and consistent manner.
** To act as primary Medical Information contact for hospital products.
** To have a current knowledge of all relevant guidelines and directives.
** To log, follow-up (if required) and process all adverse drug reactions (ADRs) received in the appropriate manner.
** To code all ADRs using the current version of MedDRA.
** To prepare and send Individual Case Safety Reports for electronic reporting .
** To double check cases entered onto the Pharmacovigilance database by other members of staff to assure correct data entry.
** To coordinate signal detection and evaluation activities.
** To prepare Periodic Safety Update Reports, Bridging Summaries and Cumulative ADR Summaries.
** To review the worldwide literature for suspected ADRs and published safety studies upon request.
** To assist in the training of appropriate personnel in the relevant aspects of PV/ MI e.g. reception staff, emergency cover staff, sales representatives (as appropriate).
** To provide information and updates to the Pharmacovigilance Manager regularly and upon request.
** To undertake other activities as requested by the Pharmacovigilance Manager .

drpksinghania AT yahoo.com

[Guest]

CURRICULUM VITAE
RAPELLI MAHESH
E- Mail : mahesh.pharmacy.srp AT gmail.com

Objective :
To work in an organization where I can be constantly enhanced and I can contribute to the development of the organization
PROFESSIONAL EXPERIENCE :
Currently Working for GVK BIO CLINICAL RESEARCH PVT.LTD, HYDERABAD as CRA (CLINICAL RESEARCH ASSISTANT) since Jan 2010 to Till Date.

SKILLS :
- Having domain knowledge in BA/BE studies.
- Having good knowledge in Pharmacology.
- Having exposure on Bio-Pharmaceutics & Pharmacokinetics and
Pharmaceutical Technology.
- Having good knowledge in Clinical Trials.

EDUCATIONAL QUALIFICATIONS :
Course College, Board/University Percentage Year Of Passing
Certified Advance PG Diploma in Clinical Research and Clinical Data management Biorevelationz clinical Research ,Hyderabad 85% 2009
B.Pharmacy Vaageswari College Of Pharmacy (KU), karimnagar. 77%(distinction) 2008
Intermediate Paramita Jr College, Karimnagar. 84.5% 2003
S.S.C Sri Sharada Shishu Mandir High School, Mancherial. 77% 2001

Project details :
I Have done my project on “ MONITORING THE BIOAVALABILITY/BIO EQUIVALENCE STUDIES IN CLINICAL RESEARCH ORGANIGATIONS” in G.V.K Bio clinical research organization
Software skills :
- Package : Ms-Office (Creators computer pvt.ltd certified)
- Expertise in the area of Clinical Research in development of the SOP’s, Protocols, CRF’s, study reports, and various study material related to the conduct of the bioequivalence studies. Hands on setting up of the systems for BA/BE studies. Hands on the designing, conducting and monitoring of the trials and generation of the final reports as per the regulatory requirements.
- Basic knowledge on ICH, GCP Guidelines.

Job Profile :
As CRA :
- Study in charge, which includes Planning and presentation of clinical research study information, Obtaining Informed Consent, Supervision of study related activities and Clinical data review (Compliance with Protocol, GCP).
- Execute the studies as per protocol, SOPs, GCP and other regulatory requirements.
- Preparation and Review of SOP’s according to the Regulatory requirements.
- Registered the volunteers to the volunteer data bank.
- Presentation of Informed Consent form to the volunteers / study subjects.
- Verifying the documentation of the Informed Consent form for each study subject.
- Monitoring of dosing, food consumption, volunteer interaction, documentation.
- Coordinating and being responsible for the designing and preparation of Clinical Study reports, Protocols and summary reports as per regulatory requirements.
- Communication of Study Updates with Investigators, Sponsor and Project management.
- Reporting of the Adverse Events and Serious Adverse Event to the Sponsor and IEC
- Co ordination with all concerned departments for proper planning & execution of studies.
- Checking the correctness, completeness, authenticity of the CRFs; recommending the required corrective actions as and when required.
- Preparation of all pre-study, during study & post-study documents related to study execution, making them ready for monitoring & audits.
- Query resolution management of the audits related to clinical aspects and other issues in coordination with quality assurance department.
- Responsible for communication of deviations with respect to the protocol, SOP’s, GCP and the applicable regulatory requirements to the investigator for taking corrective and preventive actions.
- Training of SOP’s and other study related activities to New Joiners /Trainees.
As a Q.C Personnel :
- Performing additional responsibilities assigned by unit head
- To carry out QC checks of various phases of BA/BE studies as per SOPs and Protocols and report to Unit head
- Review of ICF and Protocol before submission to IEC & review of IEC approval process
- Verification of all screening data
- Checking of study requirements before starting the study
- Checking check-in, dosing, blood sample collection and sample separation
- Verification of study file, essential documents, clinical updates, raw data and study report for data accuracy
- Checking all log books related to project for completeness and correctness of entries
- Responsible for verification of study related documents for archival

Key Achievements :
- Experience in the field of clinical research -
(It includes Pivotal /Pilot BA/BE studies, Dose Escalating studies, Food Effect Studies,
Multiple dose / Steady state studies
Urine studies, Open label and double blinded studies etc).
- Goal-directed, results-oriented, professional with a strong clinical research background and education.
- Trained on ICH – GCP

Area of intrest :
- Clinical Research and Clinical Trails
- Drug Metabolism & Pharmacokinetics
- pharmacovigilence
- Regulatory affairs

ACHIVEMENTS :
- Best student award 2003 intermediate in paramita jr college.
- Out going performance award in biostatistics and computer applications (80/80)in vaageswari college of pharmacy.
- Many awards got in college sports.

STRENGTHS :
- Good hold on communication skills, writing and word processing skills.
- Good logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
- Good analytical skill, aptitude for problem solving and making critical decisions.
- Working under deadlines and strongly adaptable.

[Guest]

Curriculum Vitae
Dr. JYOTI NEGI
Email : jyoti85_ng AT yahoo.co.in

Objective :
Seeking position with a quality dental office team, where my professional skills and ability to develop rapport and trusting relationship with patients, can be utilized .
Educational Qualifications :
Exam Passed Univ/Board Year of passing Percentage
10th C.B.S.E 2001 75.6%
10+2 C.B.S.E 2003 71.6%
B.D.S H P U 2009 58.5%
Work Experience :
- Worked proficiently in all the Departments during one year internship in M.N. DAV Dental College, Solan
- Worked in private clinic during internship.
Professional Skills :
- Good knowledge of dental tools and equipments.
- Examining X-Rays, filling cavities, scaling and root planning, splinting.
- Capable to perform surgical procedures such as impactions, alveolectomies.
- Proficient in Root Canal treatment.
- Able to give preventive information on teeth related disease and provide effective oral hygiene techniques.
Strength :
- Can coordinate well with other team members and communicate well with patients to understand their specific problems.
- Meticulous in work approach.
- Diligent in administering treatment and have been appreciated for work done.
- Have good communication skills.
Special Ability :
Positive attitude, quick learner and patience.
Social Dental Services :
- Attended many free dental diagnosis and treatment camps all around Himachal Pradesh.
- Organized free camps at rural areas near Solan, H.P. under reputed dentist and Post graduates.
Awards and Accreditions :
- Participated and won prizes in debates at school level.
- Actively involved in organizing the college annual festival.
Hobbies :
Interacting with people, travelling and listening music.
Declaration : I hereby declare that the above facts given by me are true to the best of my knowledge and belief.
JYOTI NEGI
Date :
Place :

[Guest]

Respected Sir,
I am sayan chowdhury from bolpur santiniketan,birbhum (west bengal). sir, i am giving my cv, after receiving my cv if there are any vacancy for the post of clinical research associate then please inform me kindly.

CURRICULUM VITAE (C.V) :
A. PERSONAL DETAILS :
NAME : SAYAN CHOWDHURY
ADDRESS : BOLPUR,BIRBHUM (WB), PIN-731204
E-MAIL ADDRESS : sayanchwdhr AT gmail.com
DATE OF BIRTH : 07.09.1989
SEX : Male.
MARITIAL STATUS : Single
NATIONALITY : Indian
REGION : Hindu

B. LANGUDGE KNOWN :
1. Bengali (Write, Speak, Read)
2. English (Write, Read)
3. Hindi (speak)

C. EXTRA KNOWLEDGE :
Basic knowledge of computer
1. Microsoft Word,
2. Microsoft Excel.
3. Power Point.

D. HOBBY :
1. Playing Football
2. Riding Byke

E. EDUCATION QUALIFICATION (GENERAL) :
Secondary Education Bolpur NNB High School 2005 61%
Higher Secondary Bolpur NNB High School 2007 (Science) 55%

F.EDUCATION QUALIFICATION (TECHNICAL) :
W.B.U.T Bengal school of technology passed out 2011 B.Pharma 72%
FOCUS INSTITUTE OF CLINICAL RESEARCH POST GRADUATE PROGRAM IN CLINICAL RESEARCH passed out 2012 1st Class

G. TRAINING EXPERIENCE :
Name of Company
DRAKT INTERNATIONAL PVT.LTD One month

JOB EXPERIENCE : Now I am an employee of Modi Mundi Pharma PVT.LTD.
I have joined this company on 28th’Oct 2011 as a medical representative.
Moreover I have also drug dispensing experience in a retail medicine shop for one year.

H. CAREER OBJECTIVE :-
I want to get a great opportunity with great responsibility, which will allow me to enrich my knowledge & experience with which I can set a better life style.

[chenchireddy]

RESUME :
CHENCHI REDDY LAKKU E-mail : chenchireddypharma AT gmail.com
NELLORE(DT)

OBJECTIVE :
To get a job in a reputed organization where I can use my skills for the growth of the institution, which in turn helps me for the further enhancement of my career.

EDUCATIONAL QUALIFICATION :
COURSE BOARD/UNIVERSITY INSTITUTION PERCENTAGE YOP
B.PHARM ANDHRA UNIVERSITY BHASKARA INSTITUTE OF PHARMACY (CGPA) 7.O/10. 2008-2012
INTERMEDIATE BOARD OF INTERMEDIATE EDUCATION SRI VIVEKANANDA JUNIOR COLLEGE 71.00 2004-2006
SSC BOARD OF SECONDARY EDUCATION SRI VIVEKANANDA HIGH SCHOOL 80.04 2004

PROJECT WORK :
Formulation and evaluation of FLOATING DRUG DELIVERY SYSTEM OF ONDANSETRON FOR CONTROLLING POSTCHEMOTHERAPY INDUCED VOMITING .

COMPUTER SKILLS :
Basic Skills (MS Office,MS word)

SUMMARY :
Capacity for work within completing given tasks within dead lines. Believing and practicing positive mental attitude.

PERSONAL SKILLS :
- Ability to work both independently and collectively to achieve objectives.
- Quick learner.
- Having good team spirit and leading skills.

STRENGTHS AND HOBBIES :
- Hard Working.
- Ability to work under pressure.
- Self Motivated.
- Learn new concepts

PERSONAL INFORMATION :
Name : chenchireddy lakku
Father’s Name : Basi reddy Date of Birth : 05/06/1989 Sex : Male. Nationality : Indian. Languages Known : English, Telugu,Hindi. Present Address : chenchireddy lakku

DECLARATION :
I hereby declared particulars furnished above are complete and correct to best of my knowledge and belief.
Date :
Place : (L.chenchireddy)