CAREER OPPORTUNITIES FOR THE PHARMACEUTICAL PROFESSIONALS IN PHARMACEUTICAL INDUSTRY

Abstract:

Objective of this article is to highlight the scope of career opportunity for the pharmacy professional in Pharmaceutical Industry. Although job avenues for pharmaceutical professionals are with pharmaceutical industry, government departments, universities, teaching, hospitals, investigation and research institute etc, present discussions is restricted mainly to point out the career opportunity of pharmaceutical professionals in Industry. At the outset the article depicts the portrait of vast and growing industry pharmaceutical industry. Article also discusses the qualification, knowledge and skill required for job in various departments of industry. Within the pharmaceutical industry pharmacy professional might be involved in activities relating to the discovery, development, action, safety, formulation, production, quality control, quality assurance, packaging, storage, or marketing of drugs for clinical use. There is ample scope of research for the pharmacy professional in India and abroad. Bioinformatics and Medical Transcription are the two best options for job opportunity and career advancement for the pharmaceutical professionals. There is huge career opportunity for pharmaceutical professionals in pharmaceutical industry.

Key Words: Pharmaceutical professionals, career opportunity, Pharmaceutical industry

Introduction:

From ancient times pharmacy was known as a branch associated with healthcare services. Pharmacy is the branch of science that is concerned with the discovery, development, production, and distribution of drugs. The word pharmacy was derived from the Greek word pharmakon , which means remedy, and from the Egyptian term ph-ar-maki , which means bestower of security¹. Drugs are substances used to diagnose, prevent, cure, mitigate or relieve the symptoms of a disease. They may be of plant, marine or chemical origin. Today, the discipline of Pharmacy has made enormous advancement and has matured as a distinctly independent branch as pharmaceutical sciences, mainly through the acquisition of the wealth of knowledge, research and a vast array of drugs & therapeutic remedies. Unlike the other curricula Pharmacy is a product, as well as, service related discipline, increasing its scope two-fold. India has a lot of growing pharmaceutical industry. Increasing number of hospitals, nursing homes pharmaceuticals companies and research centres all over the country is a clear indication of the growing scope in this area. Pharmacy offers reasonably good career opportunities both by way of jobs as well as in terms of starting your own business. The job avenues for pharmaceutical professionals are with pharmaceutical industry, government departments, universities, teaching hospitals, investigation and research institute etc. Within the pharmaceutical industry pharmacy professional might be involved in activities relating to the discovery, development, action, safety, formulation, production, quality control, quality assurance, packaging, storage, or marketing of drugs for clinical use ². There is ample scope of research for the pharmacy professional in India and abroad. Drug control administration also offers a wide range of opportunities to pharmacists. Plethora of opportunities is also available in sale promotion work as medical representatives. As a Medical Representative pharmacy professional keeps the medical practitioner informed about the new drugs and treatments developed by various pharmaceutical companies and thus indirectly promote their sales. In recent time few more area is added to scope of career opportunity for the pharmacy professional. Among them Bioinformatics and Medical Transcription are the two best options for job opportunity and career advancement. Pharmacy profession has a large socio-economic importance to the Indian economy. In India pharmaceutical industry is among the future economy drivers. It is committed to deliver high quality drugs and formulations at an affordable price, so that majority of people can afford them. Thus, today's pharmacy professional is a ''drug expert'' in the real sense. The transformation of the sector from conventional pharmacy to drug experts, which is both desired and necessary to reach the global standards, has already made commendable progress. The profession of pharmacy has transformed into a hub for the ''Global Healthcare'' and evolved as a multidisciplinary, multifaceted curriculum. Before going into the details of the career opportunity of the pharmacy professional in industry it is prudent to give some highlight the scenario of Indian Pharmaceutical Company.

Scenario of Indian Pharmaceutical Industry: 

a)   The Indian pharmaceutical sector has come a long way, being almost non-existent before 1970 to a prominent provider of healthcare products, meeting almost 90% of the country's pharmaceuticals needs for bulk drugs, drug intermediates and formulations.

b)   Globally, the Indian Pharmaceutical industry ranks 4^th in terms of volume (8% market share) and 13^th in terms of value (with share of 1% in global sales).

c)   Large, Medium & small Pharma players totalling about 24000 manufacturing units are in INDIA employing about 1.5 million people.

d)   Indian Pharma companies produce about 20-22% of the World’s generic drugs (in terms of value).

e)   The generic business remains one of the major drivers of growth for Indian Pharma Company. India is among the top three generic drug producers worldwide.

f)    In 2006 Indian Pharma market was 7.42 billion USD. Out of which domestic market contributed was 2.61 billion USD and export market contributed was 4.81 billion USD.

g)   37% of the total Drug Master Filing (DMF) submitted worldwide during 2006 by the Indian Pharmaceutical Company.

h)   India has the largest number of USFDA –approved plants outside of the United States.

i)     Leading pharma companies are investing lot of money in R & D.

j)    Strength of industry - low developing cost, effective technologies, excellent human resources.

k)   Indian emerging as the hub for collaborative research, co-development and Co- marketing.

The Indian pharmaceutical industry is a success story providing employment for million and ensuring those essential drugs at affordable prices are available to the vast population of this sub-continent.

Secret behind the success of Indian Pharmaceutical Company

Competent workforce:

India has a pool of personnel with high technical and managerial competence as also skilled workforce. It has an educated and diligent work force. English knowledge of Indian is another added advantage which Chinese and Japanese are lacking. Professional services are easily available.

Cost -effective chemical synthesis

Its excellent track record of development, particularly in the area of improved cost-beneficial chemical synthesis for various drug molecules. It provides a wide variety of bulk drugs and exports modern bulk drugs.  

Low developing cost

Formulation development cost is low in India due to cheap raw materials, packaging materials and equipment and machinery and workforce.   

Legal & Financial Framework

India has a 62 year old democracy and hence has a solid legal framework exists throughout the country and it has strong financial markets. India is one the emerging economic market. There is already established international industry and business community.  

Information Technology

It has a good network of world-class educational institutions and established strengths in Information Technology.  

Globalization

The country is committed to a free market economy and globalization. Above all, it has a 70 million middle class market, which is continuously growing. Liberalization, Privatization and Globalization (LPG) have helped the Indian pharmaceutical companies to achieve international recognition. India’s pharmaceutical export volume is much higher than its domestic volume. This signifies that quality of Indian medicines is of international standard and is accepted worldwide. It's remarkable to note that today several Indian pharma companies are approved by US FDA and are listed at NASDAQ.

Career Opportunity Of Pharmacy Professional In The Pharmaceutical Industry

Pharmacy professional has excellent career opportunity in the following areas of Pharmaceutical Industry.

·         Manufacturing /Production

·         Pharmaceutical Production Management

·         Quality Control

·         Quality Assurance

·         Research & Development

·         Clinical Research

·         Contract Research Organization

·         Regulatory Affairs & IPR

·         Sales & Marketing

·         Product Management

·         Bio-Informatics

·         Medical Transcription

Manufacturing & Production

A Pharmacy professional works in the production of Bulk Drugs (API) & Intermediates and Formulation as a

·         Production Chemist (Competent Technical Staff)

·         Production Officer

·         Production Executive

·         Production Planner

·         Production Manager

·         Vice President - Production

Pharmacy professional also works in the production department of:

·         Biological & Biotechnological products

·         Ayurvedic Product

·         Homeopathic Medicines

·         Unani System of Medicines

·         Surgical dressings

·         Medical Devices & Equipment

·         Veterinary medicine

·         Perfumery

·         Pharmaceutical Flavors & Fragrances

·         Nutraceuticals

·         Cosmetics, Soaps, Toiletries segment

·         Blood and Plasma Products - Blood of various groups, production of blood bags, Haemoglobin,  plasma, serum, clotting factors Antigens, antibodies etc.

·         Dental Medicines and dental products - tooth paste, mouthwashes, dental cavity fillers etc.

Prerequisite for personnel work in Manufacturing/Production

Degree required:

B. Pharm., M. Pharm.

Knowledge and Skill required:

·         Through understanding of production processes

·         Thorough knowledge of dosage form manufactured

·         Knowledge of pharmaceutical machinery for production

·         Knowledge of Critical Control Points (CCP) of production processes

·         Lucid understanding of GMP requirements.

·         Extraordinary management skills

Pharmaceutical Production Management

Although this is related to production, Industrial Production Management is mainly concerned with the organization of Raw Material, machinery and labour to produce desired product taking care of Quality & Quantity.

Production Manager is responsible for production schedule, staffing, procurement and maintenance of equipment and coordination of production activities among different departments. They also take care of economic efficiency and in-time delivery of the products.

They are also aware recent market trends and the resultant change in the demand pattern. Pharmacy professional has very good career opportunity in Production Management.

Prerequisite for personnel work in Pharmaceutical Production Management

Degree required:

B. Pharm., MBA (Production Management)

Knowledge and skill required:

·         Knowledge of technical aspects of the production processes

·         Extraordinary management skills

·         Capacity to map out effective planning

Quality Control

Quality Control is the part of Quality management focused on fulfilling quality requirements. They are dealing with Sampling, Inspecting, Testing, Monitoring, Releasing/Rejecting of starting materials, Packaging materials, Intermediates, Bulk products Finished products.

Highly specialized and trained staff is required to handle sensitive analytical procedures & sophisticated equipment.

A Pharmacy professional work as a

Ø  QC Chemist (Competent Technical Staff)

Ø  QC Executive

Ø  Technical Manager - QC

Ø  QC Manager

Prerequisite for personnel work in Quality Control

Degree required:

B. Pharm., M. Pharm.

Knowledge and skill required:

ü  Knowledge of Good Laboratory Practices (GLP) norms

ü  Thorough knowledge of analytical chemistry

ü  Knowledge of instrumental method of analysis – UV-VIS spectroscopy, HPLC, IR spectroscopy,   NMR, Mass Spectroscopy, Atomic Absorption Spectroscopy (AAS) etc.

ü  Thorough knowledge of microbiology for personnel working microbiological section of QC.

ü  Thorough knowledge of packaging materials testing procedure for personnel working in Packaging Control section of QC. §Knowledge of pharmacopoeias like IP,BP,USP

ü  Knowledge of Analytical Method Validation

ü  Knowledge of basic statistical tools - SQC

Quality Assurance

Quality Assurance is the part of the Quality Management focused on providing confidence that quality requirements will be fulfilled

QA is wide ranging concept concerning all matters that individually or collectively influence quality of product. QA is the totality of the arrangements made with object of ensuring that products are of the quality required for intended use. They ensure product quality starting from procurement of raw materials up to the marketing of manufactured product. Their role is to implement and maintain Quality Management System (QMS) needed for building the confidence that manufactured products are of standard quality with minimum risk of rejection and maximum customer satisfaction.

Pharmacy professionals work as a

·         QA Inspector

·         QA Executive

·         Document Controller

·         QMS - Co-ordinator

·         Validation Co-ordinator

·         QA Manager

Prerequisite for personnel work in Quality Assurance

Degree required:

B. Pharm., M. Pharm.

Knowledge & Skill required:

·         Understanding of  QMS - ISO 9001:2008 QMS requirements

·         Thorough understanding of National GMP requirements

·         Through knowledge of Production processes

·         Through knowledge of Facility System e.g. water system, HVAC system

·         Through knowledge of analytical test methods/ Pharmacopoeias

·         Sampling plan

·         Statistical Process Control (SPC)

·         Validation Approach

·         Qualification of Equipment

·         Calibration

·         Documentation & Document Management System

·         ICH guidelines

·         Knowledge of Drug Rules & Act & other relevant regulatory Affairs

·         Auditing Technique

 Research & Development

R & D is the heart of Pharma industry, as it is the key to growth and sustenance of the industry.

In R & D Pharmacy professional works in the following areas :

·         New Drug Discovery Research (NDDR)

·         Process Development (P &D) of API - development of viable processes for the manufacture of   drugs & intermediates for their commercial production

·         Formulation & Development ( F & D) of Conventional and Novel Drug Delivery Systems

·         Pharmacy professional work as a

·         R & D Chemist

·         R & D Executive

·         Research Scientist

·         Research Associates

·         Group Leader - R & D

·         Head - R & D

·         Vice  President - R & D

Prerequisite for personnel work in Research & Development

Degree required: M. Pharm., Ph.D.

Knowledge and skill required:

·         Sound knowledge of dosage forms and dosage form design

·         Knowledge of scale up of production processes

·         Basic knowledge on biopharmaceutics

·         Knowledge of analytical method development and validation

·         Those who will be in drug discovery division they should have sound knowledge organic chemistry and synthesis

·         Knowledge of QSAR and computational chemistry

·         Knowledge of handling software for drug development

·         Statistical experimental design.

·         Finally research mindset and capacity to think innovatively.

Clinical Research

Pharmacy professionals have high demand in the areas of

·         Clinical trials

·         Bioequivalence Study

·         Pharmacokinetics study and

·         Toxicological Studies

These are the some of the areas of clinical research, which are in high demand as they are involved in the systematic evaluation of potential drug substances prior to getting them approved by the regulatory authorities.

Pharmacy professionals have job potential in the Clinical Research in the following position:

·         Clinical Training Analyst

·         Clinical Research Monitor

·         Clinical Research Associate

·         Clinical Affairs – Project Manager

·         Clinical Trials Manager

·         Clinical Research Coordinator

Prerequisite for personnel work in Clinical Research

Degree required: M. Pharm., Ph.D

Knowledge and skill required:

·         Knowledge of Biopharmaceutics

·         ICH-GCP guidelines,

·         FDA and foreign regulatory requirements and

·         Project management of clinical studies

·         Role of statistics in designing clinical research protocols

·         Multivariate statistics and/or Design of Experiments (DOE).

Contract Research Organization (CRO)

Various Contract Research Organization are already established in different parts of India who are doing research for the big national & international pharmaceutical companies in the areas of New Drug Discovery, Process Development, Formulation & Development and Clinical Research.

There are lots of job opportunities for the Pharmacy professionals in this CRO at different level.

Regulatory Affairs (RA) and Intellectual Property Rights (IPR)

Every Pharmaceutical Industry has now set up Regulatory Affairs Department. Pharmacy Professionals are the pivotal people in this department at different level and position. Regulatory Affairs offer a lot of job opportunities.

They are required for

Ø  Interaction with all departments of the company and based on this cooperation prepare a variety of documents necessary for research, development and production of drugs/medical devices.

Ø  Providing information and expertise in the latest changes in the Regulatory Requirements of   National GMP, WHO- GMP, US FDA, TGA, ICH guidelines.

• Ø  Preparing for Regulatory Inspection
• Ø  Interaction with government to obtain regulatory approval (licensing) for production of therapeutics.
• Ø  Interaction with government to obtain regulatory approval for conducting clinical studies and for production of therapeutics.
• Ø  WHO Certification
• Ø  Intellectual Property Rights (IPR)& Pharma Patents
• Ø  Preparation of Drug Master Files (DMF), New Drug Submission (NDS)/ Abbreviated New Drug Submission (ANDS)/Common Technical Document (CTD)
• Ø  Preparation of Registration Dossier for export
• Ø  These professionals will find employment in industry as
• Ø  Regulatory Affairs Assistants,
• Ø  Regulatory Affairs Associates,
• Ø  Documentation Administrators and Medical Information Associates ,
• Ø  Regulatory Affairs Consultants for Pharma/Biotechnology Industry,
• Ø  Regulatory Food Safety Scientist,
• Ø  Pharmaco-vigilance Manager,
• Ø  Drug Safety Specialist

Prerequisite for personnel work in Regulatory Affairs & IPR

Degree required: M. Pharm., Ph.D.

Knowledge and skill required:

Ø  Important aspects of Indian Drug Rules & Act

Ø  GMP requirements

Ø  International Regulatory Affairs & Harmonization  and ICH Guidelines

Ø  WHO Guidelines on Good Manufacturing Practices & WHO   Certification

Ø  Intellectual Property Rights (IPR)& Pharma Patents

Ø  Preparation of Drug master files, New Drug Submission (NDS)/ Abbreviated New Drug Submission (ANDS)/Common Technical Document (CTD)

Sales & Marketing

Medical sales representatives are a key link between pharmaceutical companies and medical and healthcare professionals. They work strategically to increase the awareness and usage of a company’s pharmaceutical and medical products.

They also promote products to the different organizations, and Government as well.

Based in a specific geographical location and they usually specialize in a particular product or medical area viz. cardiovascular division, Diabetes division, Gynecological division, Psychiatric division etc. They may also make presentations and organize group events for healthcare professionals, as well as work with contacts on a one-to-one basis.

The Pharma sales & marketing is highly technical field & offers excellent opportunities for the pharmacy graduates.

Pharmacy professional starts their career in sales and marketing career as Medical Representative and go up to the levels of

·         District Manager,

·         Area Manager,

·         Regional Manager and

·         Manager- International Marketing & Exports.

Prerequisite for personnel work in Sales and Marketing

Degree required: B. Pharm.

Knowledge and skill required:

·         Knowledge of pharmacology & medicinal chemistry

·         Selling skills

·         Communication skills

·         Presentation skills.

·         Patience

·         Planning

·         Time management

·         Query handling skills

·         Soft skills for reporting

·         Energy & Enthusiasm, Teamwork & Co-operation.

  

Product Management

B. Pharm. with MBA (Marketing) after few years of experience in sales and marketing can works as a member of the Product Management Team (PMT).

Their responsibilities are

·         Market Research

·         Benchmarking

·         Strategizing and positioning of product

·         Give lead to next products to be developed at R & D

·         Promotional activities etc. 

Prerequisite for personnel work in Product Management

Degree required: B. Pharm., MBA (Marketing)

Knowledge and skill required:

·         Excellent verbal and written communication skills

·         Ability to effectively communicate value proposition and technical information to a range of   customer and Medical Representative

·         Experience in developing and presenting technical materials

·         Ability to lead people and management skills

·         Clear vision about the business growth

·         Positive attitude, creativity

In recent time Bioinformatics and Medical Transcription are two major areas are added to the scope of career opportunity for the pharmacy professional. 

Bioinformatics

Bioinformatics is the application of information technology to the field of molecular biology. The primary goal of Bioinformatics is to increase our understanding of biological processes.

Major research efforts in the field include

·         sequence alignment,

·         genetic finding, genome assembly

·         protein structure alignment

·         protein structure prediction

·         prediction of gene expressions

·         protein-protein interactions

·         modelling of evolution 

Pharmacy professional with knowledge of computer application & software has job potential in the Bioinformatics in the following position:

·         Bioinformatics Trainee

·         Bioinformatics Analyst

·         Scientist/Senior Scientist - Bioinformatics

·         Team Leader - Bioinformatics

·         Bioinformatics - Trainer

·         Bioinformatics  - Lecturer to Professor

Prerequisite for personnel work in Bioinformatics

Degree required: B.Pharm., M. Pharm., Ph.D.

Knowledge and skill required:

·         Mastery in Molecular cell biology

·         Sound knowledge of Biochemistry

·         Statistical Methods

·         Expertise in Computer application

·         Knowledge of software development

Medical Transcription

Medical transcription, also known as MT, is an allied health profession, which deals in the process of transcription, or converting voice-recorded reports as dictated by physicians and/or other healthcare professionals, into electronic format. A medical transcriptionist is the person responsible for converting the patient's medical records into electronic format.

Due to the increasing demand to document medical records, countries particularly USA started to outsource the services of medical transcription. Since India is several hours ahead of America and Europe, Indian medical transcription industries can offer the natural advantage of quicker turnaround time. That is why India is chosen as the one of the best source of outsourcing in MT.

Typical MT firm is structured as follows:

·         Trained medical transcriptionist

·         Senior medical transcriptionist

·         Proofreaders

·         Sub editors

·         Editors

·         Supervisor

·         Manager

Prerequisite for personnel work in medical transcription

Degree required: B. Pharm

Knowledge and skill required

·         Knowledge of medical terminology

·         Above-average spelling, grammar knowledge

·         Communication and memory skills

·         Ability to sort, check, count, and verify numbers with accuracy

·         Skill in the use and operation of basic office equipment/computer

·         Ability to follow verbal and written instructions

·         Records maintenance skills or ability

·         Good to above-average typing skills

·         Pharmacy professionals also have job opportunities in

·         Pharmaceutical Packaging materials manufacturing companies

·         Pharmaceutical Machine & equipment manufacturing companies

·         Pharmaceutical Journalism

 ….. And many more opportunities are there for Pharmacy professionals in industry.

Conclusions:

Indian pharmaceutical company holds a strong position in global pharma market. 24000 registered pharmaceutical companies in India are providing huge opportunities for employment for pharmacy professionals. Career advancement opportunities are excellent for those skilled and experienced.

Indian pharma companies strongly withstand the pressure of recent global recession. While other industries like IT industry, automobile industry etc. where there is huge job loss during the period of global recession, pharmaceutical companies remains almost unaffected. It shows job security is higher for the pharmacy professional in pharmaceutical industry. As of today, there are plethora of job opportunities, career advancement and job security for the pharmacy professionals in pharmaceutical Industry in India.

Reference:

1.   Indian Pharmacy Reference Guide 2007-2008. Sec – I, 3 –6.

2.   Saigal N, Baboota S, Ahuja A, Ali J. USFDA generic approval process, IJPER 2009, 43 (3), 232-240.

3.   Kulkarni S K. D. Pharm. or Pharm. D.: A professional chirality?, IJPER 2009, 43 (2), 114-116.

4.   Singh B, Katare O P. Need of quality education for changing pharma world, IJPER 2009, 43 (2), 203-218.

source