A placebo is a pill or liquid that looks like the new treatment but does not have any treatment value from active ingredients.
Saturday, 18 April 2015
Wipro | Hiring for Group Leader for Pharmacovigiliance-Delhi
WIPRO BPO
HIRING FOR GROUP LEADER ( Pharmacovigiliance)
ROLES & RESPONSIBILTY :
o Complete case processing in ARISG (Adverse reaction information system global) database.
o Pharmacovigiliance process operations management.
o Proven aptitude to analyze and translate complex customer requirements and business problems and design/implement innovative custom solutions.
o Responsible for developing training materials and workflow related to Medical Writing and Pharmacovigiliance.
EDUCATION & EXPERIENCE:
MBBS / PHD with 1-3 years experience.
CANDIDATE SHOULD BE COMFORTABLE WORKING IN ROTATIONAL (24*7) SHIFTS.
JOB LOCATION:
New Delhi ( Sarita Vihar)
If Interested Please share your resume at Kanika.sharma8@wipro.com
HIRING FOR GROUP LEADER ( Pharmacovigiliance)
ROLES & RESPONSIBILTY :
o Complete case processing in ARISG (Adverse reaction information system global) database.
o Pharmacovigiliance process operations management.
o Proven aptitude to analyze and translate complex customer requirements and business problems and design/implement innovative custom solutions.
o Responsible for developing training materials and workflow related to Medical Writing and Pharmacovigiliance.
EDUCATION & EXPERIENCE:
MBBS / PHD with 1-3 years experience.
CANDIDATE SHOULD BE COMFORTABLE WORKING IN ROTATIONAL (24*7) SHIFTS.
JOB LOCATION:
New Delhi ( Sarita Vihar)
If Interested Please share your resume at Kanika.sharma8@wipro.com
Clinical Research Coordinator-0-1years-Bengaluru/Bangalore, Hyderabad / Secunderabad, Mumbai-Openings: 4
Salary: 1,75,000 - 2,00,000 P.A. Best in the Industry
PG:M.Sc - Any Specialization, Bio-Chemistry, Biology, Microbiology, Nursing, M.Pharma - Pharmacy, PG Diploma - Any Specialization
Desired Candidate Profile
Education-
UG: B.Sc - Biology, Microbiology, B.Pharma - Pharmacy, BDS - DentistryPG:M.Sc - Any Specialization, Bio-Chemistry, Biology, Microbiology, Nursing, M.Pharma - Pharmacy, PG Diploma - Any Specialization
APPLY HERE
Types of clinical trials in Drug Development process
There are different types of clinical trials.
- Natural history studies provide valuable information about how disease and health progress.
- Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Better approaches may include medicines, vaccines, or lifestyle changes, among other things.
- Screening trials test the best way to detect certain diseases or health conditions.
- Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
- Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.
NH Case Processing Associate-Accenture-Chennai
Job Description
Schedule : Full-time Perform single case medical assessment, including the determination of seriousness, expectedness / listedness /labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions.
Maintain the timely submission of expedited reports.
Support the achievement of the Therapeutic Areas case processing performance timelines. Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution.
Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems. Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.
Partner with Worldwide Safety Strategy and with other Worldwide Safety and Regulatory Safety Operations functional groups to monitor the safety profile of assigned products.
Actively participate in Risk Management Committees and other risk management activities for assigned therapeutic areas. Perform product safety reviews as appropriate.
Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness /listedness/labeledness, causality, and data reconciliation.
As appropriate, provide medical safety input, and review or draft sections of response documents to health authority inquiries.
Work with the Therapeutic Area Head to proactively and effectively communicate product safety issues and proposed solutions to PSSR management and to the Office of the EU Qualified Person.
Desired Profile
Medical Degree from an accredited
institution Minimum of two years of experience as an MD in clinical
practice Minimum of two years of relevant experience in
pharmacovigilance, clinical research or related field
Pharmaceutical industry experience preferred Working knowledge of
international regulations and guidance documents as related to worldwide
reporting requirements, preparation of clinical trial safety
assessments, and regulatory submissions including the preparation of
aggregate reportsEducation:UG -B.Sc - Any Specialization
PG - M.Sc - Any Specialization
APPLY HERE
Randomization
Randomization is the process by which two or
more alternative treatments are assigned to volunteers by chance rather
than by choice. This is done to avoid any bias with investigators
assigning volunteers to one group or another. The results of each
treatment are compared at specific points during a trial, which may last
for years. When one treatment is found superior, the trial is stopped
so that the fewest volunteers receive the less beneficial treatment.
http://www.nih.gov/health/clinicaltrials/basics.htm
http://www.nih.gov/health/clinicaltrials/basics.htm
Pharma Data Entry Associate-Accenture-Chennai
Job Description
Schedule : Full-time ? Organize, manage, and actively carry out as appropriate, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity.
? Carry out all case management activities as appropriate.
? Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
? Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios
? Ensure complete and timely forwarding of ICSR to Core
? Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed.
? Consistently apply regulatory requirements and Client policies
? Analyze and monitor activities, define and implement corrective actions, where applicable.
? Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database.
? Provide oversight and team mentoring on case handling aspects, data extraction, and analyses.
Desired Profile
? Health Care Professional or
equivalent experience preferred ? Minimum 4 years experience in
pharmacovigilance and/or data management, clinical care, or clinical or
scientific research required ? Experience and skill with medical
writing an advantage ? Ability to independently solve routine problems
related to case processing and surface issues constructivelyEducation:UG -B.Sc - Any Specialization
PG - M.Sc - Any Specialization
APPLY HERE
How patients are protected in research?
Ethical guidelines
The goal of clinical research is to develop knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible for this to occur. The path to finding out if a new drug is safe or effective is to test it on patient volunteers. By placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. Ethical guidelines in place today were primarily a response to past research abuses.
Informed consent
Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. The process of providing information to participants continues throughout the study. To help someone decide whether to participate, members of the research team explain details of the study. The research team provides an informed consent document, which includes such details about the study as its purpose, duration, required procedures, and who to contact for various purposes. The informed consent document also explains risks and potential benefits.If the participant decides to enroll in the trial, the informed consent document will be signed. Informed consent is not a contract. Volunteers are free to withdraw from the study at any time.
IRB review
Most, but not all, clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB) in order to ensure that the risks are minimal and are worth any potential benefits. An IRB is an independent committee that consists of physicians, statisticians, and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected. Potential research participants should ask the sponsor or research coordinator whether the research they are considering participating in was reviewed by an IRB.http://www.nih.gov/health/clinicaltrials/basics.htm
Walk - in Interview on 21st April 2015 in Quintiles
Venue Details:
Quintiles Technologies Pvt . Ltd
Wing A, Ground Floor, Etamin Block,
Prestige Technology Park II
Sarjapur Marathahalli, Outer Ring Road,
Bangalore - 560103.
www.quintiles.com
Contact Person: Thenmozhi
Registration Time: 8.00AM
Salary: 2,00,000 - 5,00,000 P.A
Desired Profile
Candidates having 0 - 5 yrs experience in Clinical research domain can walk-in.
Excellent Communication skill is mandatory.
Only First 30 candidates upto 6months experience will be allowed to attend the interview process.
Only First 30 exp candidates (1.5 yrs to 5 yrs) will be allowed to attend the interview process.
Quintiles Technologies Pvt . Ltd
Wing A, Ground Floor, Etamin Block,
Prestige Technology Park II
Sarjapur Marathahalli, Outer Ring Road,
Bangalore - 560103.
www.quintiles.com
Contact Person: Thenmozhi
Registration Time: 8.00AM
Salary: 2,00,000 - 5,00,000 P.A
Desired Profile
Candidates having 0 - 5 yrs experience in Clinical research domain can walk-in.
Excellent Communication skill is mandatory.
Only First 30 candidates upto 6months experience will be allowed to attend the interview process.
Only First 30 exp candidates (1.5 yrs to 5 yrs) will be allowed to attend the interview process.
Trainee-Clinical Research at Syntel-Pune- (For Freshers Only) - Clinical Research (0-1 Years) - 50 Opening(s)
Job Requirements:
UG - B.Tech/B.E. - Agriculture, Bio-Chemistry/Bio-Technology, B.Sc - Agriculture, Anthropology, Bio-Chemistry, Biology, Botany, Chemistry, Dairy Technology, Environmental science, Food Technology, Microbiology, Nursing, Zoology, General, B.Pharma - Pharmacy, BDS - Dentistry, BVSC - Veterinary Science
PG - M.Sc - Agriculture, Anthropology, Bio-Chemistry, Biology, Botany, Chemistry, Dairy Technology, Environmental science, Food Technology, Microbiology, Nursing, Zoology, M.Tech - Agriculture, Bio-Chemistry/Bio-Technology, M.Pharma - Pharmacy
- Candidates with diploma/course in Clinical Research will be preferred.
- Clinical Research subject knowledge
- Good Communication Skills
- MS Office knowledge
- Willingness to work in Night Shifts
UG - B.Tech/B.E. - Agriculture, Bio-Chemistry/Bio-Technology, B.Sc - Agriculture, Anthropology, Bio-Chemistry, Biology, Botany, Chemistry, Dairy Technology, Environmental science, Food Technology, Microbiology, Nursing, Zoology, General, B.Pharma - Pharmacy, BDS - Dentistry, BVSC - Veterinary Science
PG - M.Sc - Agriculture, Anthropology, Bio-Chemistry, Biology, Botany, Chemistry, Dairy Technology, Environmental science, Food Technology, Microbiology, Nursing, Zoology, M.Tech - Agriculture, Bio-Chemistry/Bio-Technology, M.Pharma - Pharmacy
APPLY HERE
Clinical Research Associate- Bio-clinical- QC-Macleods Pharmaceuticals Ltd.
1. Overseeing all implementation all project specific clinical data as a QC.
2. Coordinate with protocol preparation.
3. Preparation of clinical study reports (CSR), Project summary.
4. ICF Reviewing and obtaining of ICF.
5. Reviewing of Trial Master File.
6. Coordinate with the Volunteer Information Management System (VIMS).
7. Dosing and supervision of Investigational Product.
8. Preparation of clinical reports.
9. Preparation and compilation Case Report Forms (CRF) of pilot and pivotal
10. Thorough with the in-house SOPS, ICR and GCP guidelines.
Desired Candidate Profile
Education-
UG: B.Pharma - PharmacyPG:M.Pharma - Pharmacy
APPLY HERE
Various Types of Clinical Trials being conducted in India
- Trials are on for drug which is indicated for reduction of mortality in adult patients and can be used for sepsis. Clinical Trials have already been held on more than 600 patients for human insulin and insulin. Clinical Trials are being conducted on oncology and developing a new molecule for lung cancer.
- Clinical trials are on 300 patients on a new malaria 'cocktail' drug that combines chloroquine (to which Indian malarial strains have developed resistance) and azithromycin, an antibiotic. Clinical Trials are also being conducted for drugs to treat osteoporosis, breast cancer and schizophrenia.
- Global trials are on in India for treatment of a particular variant of lung cancer. One of the reasons for considering India is that it has a vast patient population infected by this type of lung cancer, which is primarily triggered by use of tobacco products. India is also being considered a prospective site for future clinical trials involving new drugs and therapies for treatment of different variants of blood cancer and colorectal diseases.
- The trials in India are mostly in different areas like oncology, endocrinology, traumatology, sports medicine, pulmonary diseases, paediatric diseases, and infectious diseases.
- The largest Clinical Trial outside US for a drug delivery device has been conducted in India.
What is contract research organization (CRO)?
A contract research organization (CRO) is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced
on a contract basis. A CRO may provide such services as
biopharmaceutical development, biologic assay development,
commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance.
CROs also support foundations, research institutions, and universities,
in addition to governmental organizations (such as the NIH, EMA, etc.).
Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.[2] CROs range from large, international full-service organizations to small, niche specialty groups.
CROs that specialize in clinical-trials services can offer their clients the expertise of moving a new drug or device from its conception to FDA/EMA marketing approval, without the drug sponsor having to maintain a staff for these services.
To know more about drug development process, be a certified clinical research professional, click here to get a certification.
Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.[2] CROs range from large, international full-service organizations to small, niche specialty groups.
CROs that specialize in clinical-trials services can offer their clients the expertise of moving a new drug or device from its conception to FDA/EMA marketing approval, without the drug sponsor having to maintain a staff for these services.
To know more about drug development process, be a certified clinical research professional, click here to get a certification.
Clinical Research Industry - An Indian Perspective Clinical Research - The Future
India has become a signatory to TRIPS. Consequently, a new
patent law has come into effect from January 2005. The new
keyword for the pharmaceutical industry is innovation and
to introduce new drugs, clinical trials are mandatory. They
are to be conducted as per ICH GCP norms. The clinical trials
that have been conducted in India till date have gone well.
For majority of the studies, patient enrollment is a key advantage.
This helps compress the development timeline and data quality
is excellent.
Numerous audits in India are a testimony to level of quality. And data from clinical study in India have been successfully filled with international regulatory agencies. The potential realized at present is a fraction of the possible in India. Consistent with WTO guidelines effective from 2005, India will also offer 10-year tax concessions on revenue to companies making Research & Development (R&D) investments here. These incentives are expected to substantially increase R&D activities of both multinational and domestic biopharmaceutical companies.
Analysts are projecting that total Clinical Research spending in India will increase by more than 30% annually through 2015.
Numerous audits in India are a testimony to level of quality. And data from clinical study in India have been successfully filled with international regulatory agencies. The potential realized at present is a fraction of the possible in India. Consistent with WTO guidelines effective from 2005, India will also offer 10-year tax concessions on revenue to companies making Research & Development (R&D) investments here. These incentives are expected to substantially increase R&D activities of both multinational and domestic biopharmaceutical companies.
Analysts are projecting that total Clinical Research spending in India will increase by more than 30% annually through 2015.
India is increasingly being recognized as a hub for global clinical trials as it has several prized attributes:
- Large and diverse patients' pool for conducting clinical trials
- Availability of Medical, Pharmacy and Science graduates
- Excellent infrastructure facilities
- Comparative cost advantage
- Changes in the Patent Laws
The Clinical Research industry in India has grown from Rs 20 crores to Rs 100 crores in the last three years. As per a recent McKinsey report, it is expected to touch Rs 5,000 crores by 2015 and will employ 1,50,000 people in the next five years.
There will be a huge demand for qualified and trained Clinical Research Professionals.
Many pharmaceutical organizations and Clinical Research organizations have already come forward to unlock the vast potential that India has, and are conducting Clinical Trials in India.
Click here to be a Certified Clinical Research Professional .
4 Phases of Clinical Research
Phase I trials
This is the first time the new drug is administered to a small number, around 20-80 healthy, informed volunteers under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.
Phase II trials
In this phase, the medicine is administered to a group of approximately 100-300 informed patients to determine its effect and also to check for any unacceptable side effects.
Phase III trials
In this phase, the group is between 1000 and 5000, for the company to use statistics to analyze the results. If the results are favourable, the data is presented to the licensing authorities for a commercial licence.
Phase IV trials
This is a surveillance operation phase after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.
This is the first time the new drug is administered to a small number, around 20-80 healthy, informed volunteers under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.
Phase II trials
In this phase, the medicine is administered to a group of approximately 100-300 informed patients to determine its effect and also to check for any unacceptable side effects.
Phase III trials
In this phase, the group is between 1000 and 5000, for the company to use statistics to analyze the results. If the results are favourable, the data is presented to the licensing authorities for a commercial licence.
Phase IV trials
This is a surveillance operation phase after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.
About Drug Development Industry
Clinical research industry:
The global pharmaceutical market is estimated at US$ 427 billion and Research & Development cost is estimated at US$ 60-65 billion annually. Two thirds of this amount is spent on Drug Development, i.e., approximately US$ 40 billion. Clinical Trials involve almost 70% of time and money of new Drug Development. Cost of conducting Clinical Trials for a new drug is approximate US$ 200-250 million.Clinical Research Industry has grown around the world at an unparalleled rate in the past few years. It has opened up new vistas of employment for a large number of people. The Clinical Trials market worldwide is worth over US$ 45 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK and they form one third of the total Research & Development staff.
Get Certification and Experience togther !!!!
Informative for career opportunities in drug development industry
for all the bio-science, pharmacy, medical graduates and post
graduates.visit us at www.coreclinical-services.com
Pharmacovigilance opening in TCS Mumbai
TCS Openings
Eligibility: M.Pharm 2014 freshers with certificates only
Process: Pharmacovigilance
Venue: Wellspring Office, LBS Marg, Vikhroli, Mumbai
Dates: 20th Monday Apr 2015
Time: 10AM to 4PM
---------------------------------
Ref Name: Murali Billakanti
Emp ID: 892163
Contact: +919029097770
Wtsapp: 9032234240
-------------------------------
Eligibility: M.Pharm 2014 freshers with certificates only
Process: Pharmacovigilance
Venue: Wellspring Office, LBS Marg, Vikhroli, Mumbai
Dates: 20th Monday Apr 2015
Time: 10AM to 4PM
---------------------------------
Ref Name: Murali Billakanti
Emp ID: 892163
Contact: +919029097770
Wtsapp: 9032234240
-------------------------------
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