Drug Development, Clinical Research, Drug Safety and Pharmacovigilance Certificate Program

Clinical Research Professionals:  Clinical research is an inevitable part of the health care system that is actively involved in drug discovery. It plays an important role in discovering new ways to detect, diagnose, and decrease the chances of developing a disease. It also aids in ascertaining the safety and efficacy of general-purpose drugs. Additionally, it attempts to find cures for acute or chronic illnesses such as Alzheimer’s, Rheumatoid Arthritis, or cardiovascular diseases, that were earlier thought to be incurable. Clinical research plays a critical role in the development of interventions that improve the overall health of the world’s population. Findings arising from such reports provide invaluable and reliable information about the benefits and side effects of potential drugs and therapies. They empower medical and health professionals to choose between alternative treatments with greater confidence.

Pharmacovigilance Professionals:  Pharmacovigilance (PV) is a process refereeing to the detection, collection, prevention, and monitoring of negative effects that may occur because of the use of pharmaceutical products and other drugs. PV services cater to a wide range of drug-related activities such as the discovery of a drug to its commercialization. It also helps with the utilization of tools and software that reviews and classifies data on drugs and pharmaceutical products.

There has been a soaring demand for pharmacovigilance services due to factors such as rising drug consumption, and the growing prevalence of chronic diseases, respiratory disorders, and cancer symptoms, among others. In addition to this, a large number of adverse drug reactions (ADRs) has added a substantial burden on the healthcare sector leading to the increased demand for pharmacovigilance.

Clinical researchers have diverse roles such as

• Recruitment and screening of participants suitable for the target study
• Briefing the participants and investigating team on how to conduct the trials
• Maintaining patient care in terms of health and progress
• Setting up trial study centers
• Monitoring the overall progress of the clinical trial
• Diligently handling all the paperwork related to trials
• Studying technical data and liaising with regulatory authorities
• Drafting drug trial protocols and methodologies
• Ensuring strict compliance of trials with rules and regulations
• Submission of all the relevant documents to funding organizations upon study completion

Pharmacovigilance positions may include a drug safety associate, drug safety scientist, drug safety manager or director, pharmaceutical information specialist, and related positions such as administrative positions and technical writers who specialize in pharmacovigilance writing. 

The duties of drug safety scientists and associates are to:

• Perform research, monitor trials, and investigate adverse effect reports. 
• Record, categorize and store data related to drugs. 
• Oversee pharmacovigilance operations, communicate with physicians, drug makers, and regulators when necessary, and ensure compliance with regulations.

Following are some key competencies that a successful clinical researcher or a pharmacovigilance professional needs to have for success.

• Good understanding of best research practices including epidemiology and research design. For instance, you’ll need to know how to develop relevant questions, formulate hypotheses you can test, and design clinical studies to gather important insights.
• Effectively tracking and interpreting data and performing statistical analytics is recommended. This can encompass a wide range, from establishing baseline criteria and determining what you are measuring and why, to creating a database to gather your findings, and determining how best to report the results in a meaningful way.
• Understanding the regulations surrounding patient safety and ethical concerns involved in your research efforts. These are important details that need to be considered throughout every phase of drug development—from protecting the safety of clinical trial participants to ensuing informed consent, to identifying and reporting adverse events, to complying with the Health Insurance Portability and Accountability Act (HIPAA).

• Working knowledge of the regulatory guidelines including FDA and ICH guidelines and concepts such as Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV).

• Ability to write and review important documents such as Standard Operating Procedures (SOP), Informed Consent, Investigator Brochures, Research Protocols etc.

• Coding and classifying adverse events using software such as MedDRA
• Additionally, you would need strong communication and leadership skills, as well as analytical thinking, problem-solving, and attention to detail. 

According to indeed.com, the average salary for a clinical research scientist is $110,518 per year in the United States.

The average pharmacovigilance salary in the USA is $105,788 per year or $54.25 per hour. Entry-level positions start at $66,300 per year while most experienced workers make up to $175,500 per year.

Successful clinical researchers or pharmacovigilance professionals typically have cross-functional training in areas such as science, pharmacy, and healthcare. In some cases, the quality assurance professionals worked first in related departments, such as administration, research, and development, regulatory, and pharmacology. However, in general, clinical research and pharmacovigilance professionals have the following:

1. University degree in sciences or healthcare-related field and
2. Strong and practical understanding of the field either through work experience or obtained by pursuing a Certificate in clinical research and pharmacovigilance.

The NAI certification aims to help you get your career started in clinical research and pharmacovigilance by building your knowledge, skills, and confidence in a practical and applied manner in the areas of importance in the clinical research and pharmacovigilance field:

• GCP and GVP for Drugs, OTC, Medical Devices and combination products, Biologics and Biosimilars
• Clinical research and pharmacovigilance knowledge and experience
• FDA, ICH, and related global regulations and guidelines
• Auditing and inspections

The certification builds your knowledge and indicates to the employer your level of motivation and interest in the industry as well as a documented proof of your knowledge. After the completion of the certification, you can confidently showcase your clinical research and pharmacovigilance skills on your resume and elaborate on them in an interview.

The certification builds your knowledge and indicates to the employer your level of motivation and interest in the industry as well as a documented proof of your knowledge. After the completion of the certification, you can confidently showcase your clinical research and pharmacovigilance, and drug safety skills on your resume and elaborate on them in an interview.

Our student services department works with you one on one to help navigate the job application process including the building of your resume, preparing for an interview, and connecting you to the industry.

You don’t have to complete the entire program. Each module will lead to its own certificate. 

Our admission counselors can help you do a skill gap analysis to pick the appropriate course depending on your level of expertise.