Frequently Asked Question For Pharma Domain

By: Mitul Shah | Views: 60342 | Date: 31-May-2010

Frequently Asked Question For Pharma Domain

Frequently Asked Question

1. What is Pharmacovigilance? 
Pharmacovigilance (PV) is the pharmacological science related to the detection, assessment, understanding and prevention of adverse effects, particularly short term side effects of medicines after marketing of the drug. Pharmacovigilance is also refered as Post- Marketing Surveillance.

2. State the benefits of Pharmacovigilance program. 
This program will increase the knowledge and importance of Pharmacovigilance in drug discovery process and Clinical Research, Pharmacovigilance is becoming an important part of drug development as it deals with the patients’ safety & efficacy of drug resulted into new job avenues. The participants after the completion of this would have new economic pursuits as Pharmacovigilance potential opportunities & growth prospects are huge.

3. Define Clinical Trials Data Management. 
CDM refers to management of data capture & data flow processes in conduct of a clinical research. It begins with design of data capture instrument & data collection, continues with data QC procedures to assure quality of all aspects of process, & ends with database closure.

4. Does CDM course require any programming skills? Do I have to do any special computer courses? 
No, not required, just the basics are sufficient. Using the data management systems will be taught in the course. No programming knowledge is required.

5. Could you mention some companies which require CDM professionals in India? 
There are many CROs and BPOs offering positions in clinical data management through out India. Major companies in India are CTS, TCS, PPD, BMS, Pfizer, Accenture, ICON, Novartis, Quintiles, Parexel, Neeman Medical etc.

6. Is there an attractive job market for Pharmacovigilance and clinical trial data management? 
Yes, it is a continually expanding industry. Trained manpower is lacking in this industry. According to a McKinsey report, the global clinical trial outsourcing opportunity in India in the pharmaceutical industry is estimated to be around $2 billion by 2010 and there will be requirement of 50,000 clinical research professionals in India alone.

7. What kind of data will I be managing? 
All clinical trial data including safety and efficacy data of drugs/agents under study.

8. What kind of data does CDM have? 
All data coming from CRF from sites (hospitals/clinics) and non-CRF data coming from clinical laboratories.

9. Can you tell me about the jobs opportunities after completing this course? 
Persons trained in Pharmacovigilance and clinical trials research will find good job options in the following sectors: 

Pharmaceutical Companies (MNCs & Indian) & Biotech companies. 
Clinical Research Organizations. 
KPOs like Accenture & Quintiles. 
Regulatory Agencies like DCG (I) & CDSCO 
Pharmacovigilance units in Medical colleges & Hospitals 

10. What is a Clinical Trial? 
A Clinical trial is a comparison test of a medication or other medical treatment (such as medical devices), versus a placebo, other medication or devices or the standard medical treatment for a patient’s condition. Clinical trial is investigation in human intended to discover or verify the effects of a drug, and / or to identify any adverse reactions to that investigational drug with the object of ascertaining its safety and /or efficacy. 

What is the requirement of manpower and professionals in the country? 
It is certain that in future as the number of clinical projects expands, there will be demand for qualified personnel. According to a McKinsey report, the global clinical trial outsourcing opportunity in India in the pharmaceutical industry is estimated to be around $2 billion by 2010 and there will be requirement of 50,000 clinical research professionals. Trained pharmacists and clinicians can plug this wide gap. They will be involved in the various aspects of clinical research starting from site-monitoring, site-management, clinical data management, data analysis, report writing, report submission, presentation and publication. 

In the field of clinical research, there is an imbalance between demand and supply with the scales tipping in favor of demand. Thus, pharmaceutical houses are hunting for trained professionals and are using bulk y pay packages to lure them. 

According to the data from Express Pharma: 
Table 1: Projected figures in respect of revenue, human power and patient load for Clinical Research in India 

Value (Million USD)
Revenue (Crore INR)
Full Time Staff Requirement
Site-Staff Requirement
Patient Load

Source: McKinsey Report
What are the career opportunities? 
Career prospects include a professional career in Clinical Research industry either as a clinical investigator, site coo radiator in at a hospital conducting clinical investigations or CRO (Clinical Research Organization).Jobs are also available in pharmaceutical industry, drug development, medical writing, biostatistics or as a Manager of Clinical Project, Clinical Research Business Development, Clinical Operations, Data Management, Regulatory Affairs and Auditing of Clinical Trials. You can build up your carrier in clinical trials as: 

Clinical Research Associate: 
The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer o r for a Contract Research Organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators. 

Clinical Research Investigator: 
TConduct BA/BE studies as per cGCP guidelines, Writing/revising SOP for clinical operations. Review of protocols, Investigators Brochures, ICF and CRFs Protocol, CRF and ICF preparation Plan & conduct of BA/BEIEC/IRB affairs-GC.

Study Coordinator: 
Study coordinators work directly with study volunteers, providing them safety and protection while collecting and managing the study data. They promote, advertise, and conduct telephone and face-to-face screenings to recruit volunteers. During the study process, they assess volunteer condition and coordinate ongoing clinical/laboratory testing and physical exams. Coordinators may assess vital signs (height, weight, blood pressure, pulse), and some are trained to collect blood/urine specimens and performing function testing. Study coordinators follow up with volunteers after the study and manage a great deal of paperwork, electronic correspondence and data. 

Data Manager / Biostatistician: 
Biostatisticians collaborate with researchers to design studies that may show the seriousness of a disease, predict a specific disease's seriousness, evaluate a new treatment, assess the safety and effectiveness of medications and increase knowledge of environmental issues. Additionally, biostatisticians participate in research design, data collection, choosing and implementing appropriate methodologies, and interpreting the results.

Regulatory Affairs Manager: 
Responsible for review & registration of documents as per country specific guidelines for ex port. Evaluation of technical data & answer to various related queries as per regulated & semi - regulated requirements. Liaison with regulatory authorities.

Clinical Trials Auditor: 
Conducts audits for the regulatory/QA function within the Clinical Trials Department in order to help assure compliance with GLP/GCP in accordance with established FDA regulations and company policies and standard operating procedures Job Requirements Normally B.A./B.S. in Science w/1-2 years of experience.

Clinical Project Manager: 
Responsible for ensuring compliance across projects to all applicable Clinical Trial regulations, guidelines, SOPs Protocols and procedures. Coordinate project start-up, project maintenance and project close-out activities, Serve as the primary contact for the Sponsor and all project team members, Direct supervisory responsibility for project Coordinators, project Assistants, CRAs, etc 

Clinical Research Manager : 
Manage interdisciplinary clinical research projects, as Project. Supervise, train, and mentor Clinical Research staff, Approve investigator study budgets and contracts, Review an d approve regulator y and administrative documents, develop protocols and approve Case Report Forms (CRFs), Review Tables and Listings generated from study data. Author Clinical Study Reports. Train CRAs on monitoring, internal procedures, and query, resolution. 

Business Development Manager: 
Identify potential clients & establish business relations & convert into real business. Responsible for all Business Development functions Meeting new clients, following up on leads, CRM. Continuously monitor the Competition and Global Market.

Drug Safety Associate : 
Manage and relay d rug safety information, maintain current knowledge of global drug safety regulations, summaries clinical safety data, participate in meetings with potential and actual study sponsors, write narratives with medical input from a physician, report SADRs to the Regulatory Authorities, participate in the training of operational staff on drug safety issues, quality control work o f other staff in the department, take on any other task as assigned by the manager or Medical Director within the capabilities of the Drug Safety Associate.

Medical Writer: 
To prepare high quality documents, manuscripts, abstracts and other communication tools (slide presentations, posters etc.) for publishing in indexed scientific/medical journals or for presentation in scientific/Health Authority meetings. 

Clinical Data Manager: 
The Clinical Data Manager (CDM) ensures complete, accurate and consistent data for reporting to regulatory bodies. A CDM is involved in the setting up, running and reporting of clinical trials. The CDM processes data using a range of computer applications and database systems to support collection, cleaning and management of patient data. 

Leading companies in Clinical Trials and Research: 
Persons trained in Pharmacovigilance and clinical trials research will find good job options in the following sectors: 

Asian clinical trials serene 
Clin invent 
Clintec international 
Dr Reddy’s lab 
Elly Lilly 
Glaxo smithkline 
IGATE clinical research 
Intass biopharmaceuticals 
Johnson & Johnson 
Lambda therapeutic research 
Lupin limited 
Matrix laboratories ltd. 
Novo Nordisk 
Roche India 
Siro Clinpharma 
Sanofi Aventis 
Torrent pharma 
Vimta labs 
Reliance life science 
Adroit insights 
Asian Clinical Trials 

Does the Institute provide Placement Assistance? 
Placement assistance is provided to all the program participants. The Institute is in touch with several reputed Clinical Trial and Pharma companies where passing out students will be placed. The institute has also tied up with several reputed Recruitment Process Outsourcing Organizations.

11. What is "Pharmaceutical Liability?" 
The term "Pharmaceutical Liability" refers to legal theories and ways to prove that a manufacturer of a pharmaceutical product, including prescription and over-the-counter medications, medical devices, dietary supplements and herbal remedies can be held responsible when its products injure people. The theories include strict products liability and negligence, though some states have statutes providing a single theory for recovering from a product manufacturer.

12. WHO defines Good Manufacturing Practices? 
WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization?” GMP covers all aspects of the manufacturing process: defined manufacturing process; validated critical manufacturing steps; suitable premises, storage, transport; qualified and trained production and quality control personnel; adequate laboratory facilities; approved written procedures and instructions; records to show all steps of defined procedures have been taken; full traceability of a product through batch records and distribution records; and systems for recall and investigation of complaints.

13. What is IPR? 
Intellectual Property Rights (IPRs) are described as “the rights given to persons over the creations of their minds” (WTO 1999). The rights conferred give creators an exclusive right over the use of their creations for a specified period of time. These rights are administered and controlled by national legislation, within a framework of international law.
Intellectual Property in simple terms refers to the creation of innovations, which are valuable to society at large through the use of the human intellect. Intellectual Property Rights (IPR) is the rights granted by the state to creators of such value as an appropriate reward system.

14. Regulatory Affairs in Pharmaceuticals Manufacturing. 
Regulatory Affairs in Pharmaceuticals (RA in pharma), also known as Government Affairs, this field in pharmaceuticals is dealing with all aspects of government affairs , submitting products, getting license and registration of pharmaceutical products for sale and every thing. Regulatory affairs departments are there in most of the regulated industries, like pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals have responsibility in following areas: 

To Ensure that their companies comply with all of the regulations and laws pertaining to their business. 
To Work with federal, central, state, and local regulatory bodies and personnel on specific issues associated with their business, working with such agencies as the Food and Drug Administration, European Medicines Agency (pharmaceuticals and medical devices) 
To advise their company on the regulatory affairs and climate that would affect proposed activities. Describing the "regulatory climate" around issues like the promotion of prescription drugs compliance.

Pharmaceuticals industries were the first to be significantly regulated in the modern era. In 1980 the European Community (European Union) started the regulation of health care products in the member countries. The concept of regulating medicines was well established in most member countries along similar lines to the US. 

15. What are career opportunities after doing the course? 
The potential opportunities and the growth prospects in the field of Pharmacovigilance are huge. The career options are mentioned below: 

Clinical Pharmaco-vigilance Officer. 
Clinical Pharmaco-vigilance Associate. 
Regulatory Affairs Associate. 
Pharmacovigilant Monitor. 
Pharmacovigilance Manager. 

16. What are the expected Job Profiles? 
Career prospects include a professional career in Clinical Research industry either as a clinical investigator, site coordinator in at a hospital conducting clinical investigations or CRO (Clinical Research Organization).Jobs are also available in pharmaceutical industry, drug development, medical writing, biostatistics or as a Manager of Clinical Project, Clinical Research Business Development, Clinical Operations, Data Management, Regulatory Affairs. The weekend course is useful for: 

Doctors - Principal Investigator, Co-Investigator, Medical Advisor, Drug Developers, Regulatory Affairs Manager, Clinical Research Physician. 
Pharmacists, Life Science graduates - Medical writers, Clinical Research Associate, Site Coordinator, Clinical Research Manager and Drug Development Associate, 

A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance and others are considered regulatory professionals. The Pharma industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products. To maintain safety and efficacy in pharma & medical device products, regulatory agencies like US FDA,UK MHRA, EDQM, DCGI etc all over the world are imposing no of regulation. This has resulted in creation of distinct department with highly qualified professionals who will help companies meet these requirements with ease. 

Pharmacovigilance careers opportunities: 
1.Job Profile: Pharmacovigilance careers available within regulatory authorities. 
Roles: The relationship between regulatory authorities and pharmaceutical companies may at first glance appear to be pulling in different directions, but that belies their inter-dependence.

2.Job Profile: Clinical and Scientific staff. 
Roles: The main work of physicians within regulatory authorities is the assessment of data supporting applications for Marketing Authorisation Holders or of issues raised as a result of safety signals. 

3.Job Profile: Medical Assessors. 
Role: The most common role for physicians, are mainly concerned with the assessment of scientific data supporting applications new drug and abridged applications, clinical trial start-up, variations, renewals, reclassifications and pharmaco-vigilance. 

4.Job Profile: Medical Assessor Positions. 
Role: Pharmacokinetics and statistics are competencies that are frequently needed in all forms of assessment and it is worth developing these skills to a high level.

5.Job Profile: Pharmacy Technician I 
Responsibility: A pharmacy technician reports to a pharmacist. He assists in properly mixing and distributing medical prescriptions. Pharmacy technician may also perform administrative work such as stocking shelves and entering records into a computer. 

6.Job Profile: Pharmaceutical Sales 
Responsibility: A pharmaceutical sales representative develops prospects, establishes customers and sells medications to medical offices or hospitals.

7.Job Profile: Regulatory Affairs Manager. 
Responsibility: Management of regulatory submissions for pharmaceutical products for approval, with particular emphasis on ANDA submissions.

8.Job Profile: Regulatory Affairs Specialist – RAS 
Responsibility: It is recommended to have a university degree in the sciences (Bachelor’s, Master’s, PhD), whether it be in biology, chemistry, toxicology, pharmacology, etc.

17. What should be Eligibility for Clinical Trial Professionals? 
Essential Qualification Life Science Professional’s:
B. Sc Biological Science \Biotechnology\ Bioinformatics \Microbiology\Biochemistry
M.Sc Biological Science \Biotechnology\ Bioinformatics \Microbiology\Biochemistry
B.Tech\ M.Tech in Biotechnology\Bioinformatics
B. Pharma\ M.Pharmas

18. Program Methodology:- 
Prospective Participants join the program by submitting participation form with necessary participation fee. 

The Study material contains books of the respective program and kit will available with in minimum time span. 
Participants can discuss their problem, related to subject \ study material, frequently with the concern person or faculty. 
The participant will follow the following instructions during the course duration: 
Self study of the course contents. 
Participants will submit the assignment and research project, with in given time duration. 
In case , if a participants facing any problem or edge of leave the exam ,will inform to concern person before the scheduled date of Exam. 
Session interchange would be fully restricted. 
Participant would get single chance for first time enrollment. 
Re-registration must for the failure candidate. 
Participant will get Mark statement and Certificate of the program after the evaluation by examination. 

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46  + 4 =     
hiren  |  28-May-2012 15:28:09 IST
i like to recived this kind of knowladge
ADITYA RAJGURE  |  22-Jan-2017 18:30:39 IST
i am job sikr.i am ready to do any work from pharmacovigilence .
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