Optimizing benefit-risk and appropriate evidence gathering throughout the life-cycle of any product are important pharmacovigilance activities for all the stakeholders. Safety and pharmacovigilance professionals with knowledge in regulations, pre-market and post-market monitoring can survive in the ever-changing healthcare industry.
Drug safety and pharmacovigilance in areas of development and marketing of medication is extremely important element. The importance of drug safety monitoring and risk management for medicinal product developers and clinical investigators is required to protect public health, manage increasingly tight regulations and ensure the efficient functioning of drug safety or pharmacovigilance systems within pharmaceutical and biotechnology companies. The workforce of such companies should be made aware of the basic pharmacovigilance requirements. A career in pharmacovigilance and drug safety with the exception of drug safety physicians, starts with positions of drug safety officer or associate, scientist or coordinator to progress to senior specialist or management roles. Career progression in pharmacovigilance has two possible routes: management positions with successive levels to include senior drug safety manager and director; or technical positions of pharmacovigilance scientists, vigilance managers and risk management specialists in signal detection, risk management and epidemiology. Candidates find more job opportunities in private companies than in government or public sector.
The unique career in the scientific discipline of pharmacovigilance involves the role to analyse the side effects of medication and monitor the safety of drugs available in the market. The pharmacovigilance professionals follow up cases and carry out the necessary tests; monitor, assess, detect and prevent adverse effects of medicines. This discipline touches the sectors of life science, healthcare and pharmacy to help individuals mould a career path with a bright and shining future in pharmacovigilance. Candidates with a degree in zoology, botany, biotechnology, biochemistry, microbiology and genetics are eligible to pursue this field. Professionals with a few years of experience building required skills in medical coding, good understanding of medical terms, narrative and scientific writing, basic understanding of regulatory affairs and compliance to become a Drug Safety Scientist. Professionals with Post Graduate Diploma in Pharmacovigilance and experience can become a Team leader or manager in a company. There are various courses and training programs provided with an overview to acknowledge important aspects before and after marketing of products.
Certificate or diploma courses related to pharmacovigilance are available for graduates and interested candidates. James Lind Institute (JLI) offers various courses in pharmacovigilance and the duration varies from one course to another. James Lind Institute provides
- Advanced PG Diploma in Clinical Research and Pharmacovigilance
- Advanced PG Diploma in Pharmacovigilance and quality assurance
- Advanced PG Diploma in Pharmacovigilance and Data management
- Professional Diploma in Pharmacovigilance & Pharmacoepidemiology
The courses cover a variety of important aspects of reporting, report writing, basic understanding of the regulatory bodies, signal detection and risk management. The course curriculum is directed to cover basic knowledge for professionals at all levels seeking greater understanding of benefit-risk assessment, risk management, risk communication and therapeutic treatment decision-making during the life-cycle of the product.
Online training modules and courses are developed to include causality assessment, signal detection and statistical reasoning in pharmacovigilance. In-depth knowledge in specialty areas of medical writing, medical affairs and quality assurance is required in performing the duties and responsibilities of pharmacovigilance professionals towards monitoring product safety as well as assessing, detecting and preventing adverse events. Pharmacovigilance professionals can opt for various opportunities in different sectors including research and development in drug companies of traditional and conventional medicines.