Health is not just being free from disease, but wellness from the physical, psychological and social aspects. To achieve a well-balanced state, treatment of disease is primary. Such treatment demands the unequivocal necessity that the drug used to treat the disease does not harm the patient in such a way that quality of life is further diminished, or results in death. Ever since Hannah, a British girl died after being anesthetized with chloroform in 1948, the importance of drug safety, along with its efficacy became a subject of prime importance. This vigilance in finding out all aspects of a drug, positive and negative, has led to the evolution of a new branch in pharmacological science, known as Pharmacovigilance.
Pharmacovigilance
Pharmacovigilance (PV) is one of the fundamental wings of the healthcare system and pharmaceutical companies.
As per WHO, Pharmacovigilance is a branch of pharmacological science comprising the activities related to the detection, assessment, understanding, and prevention of adverse effects of the drug. Fundamentally, it is aimed to ensure guaranteed patient safety and is considered as an arm of patient care.
Pharmacovigilance is also extended to vaccines, biological, medical devices, herbal drugs, veterinary medicines, blood, and blood-related products.
Role of Pharmacovigilance system
The clinical trials of new drugs closely monitor their efficacy, immediate adverse effects, and general safety among a limited population. However, all other details like the long-term effects of the drugs, effects on the various ancestral ground, drug-drug interactions, and effects of high doses / irrational use of the drugs are essential to ascertain patient safety. This extensive safety profile can be generated by closely monitoring the effects of drugs for a longer period in actual patient population. This is known as post-marketing surveillance and is carried out by the Pharmacovigilance wing of the pharmaceutical companies, and marketing authorities.
Many pharmaceutical companies have their in-house Pharmacovigilance system or rely on outsourcing firms to carry out post-marketing surveillance to monitor the safety profile of their products.
Pharmacovigilance demand in abroad
Adverse Drug Reactions (ADRs) being one of the significant causes of the high incidence of mortality and morbidity around the world, high priority is given to the safety of the medical-related products rather than their efficacy. So, to safeguard the patients, the regulatory authorities around the world made it mandatory to have an efficient PV system for all medium and big Pharma companies. Also, an increase in the prevalence of chronic diseases, research & development, and clinical trials drives the global Pharmacovigilance needs upward.
US, Canada, European countries, UK, Middle East countries (Oman, United Arab Emirates, Qatar, Bahrain, and Kuwait), Singapore, Malaysia, Japan, Australia, and New Zealand are some of the good destinations for Pharmacovigilance job with decent packages. Some countries and their average Pharmacovigilance salaries have been listed below.
| Countries | Average salary |
| UK | £40,000 |
| USA | $61,264 (at entry level) – $253,750 |
| Canada | $41,917 |
| Singapore | SGD 53,831 |
| UAE | 17,520 (at entry level) – 48,288 AED |
As per recent research, there is an increasing demand for efficient PV officers in many countries with good salary packages, the expected global PV market by 2027 is 212 Bn US dollars.
Pharmacovigilance demand in India
- India is the third- largest producer and exporter of pharmaceutical products in the world and supplies 62% of global demand for medicines and vaccines
- The Indian domestic pharmaceuticals market turnover reached $20.03 Bn in 2019 is expected to reach $130 Bn by 2030
- There are more than 3,000 pharma companies with a strong network of over 10,500 manufacturing facilities
- India becomes a favorite destination for clinical trials and PV outsourcing because of its low cost, high degree of compliance to international guidelines, high skill set, and English language literacy
- In India, IT firms such as Cognizant, Tata consultancy services, Accenture, Oviya Medsafe, Wipro Limited, extend their PV-related services to their global Pharma clients
- Covid pandemic and surge in lifestyle-related disorders such as diabetes, hypertension propel the PV demand
With all these valid reasons it is fair enough to say the career in Pharmacovigilance looks promising in India.
Qualification needed for a Pharmacovigilance job
- Graduate/ Post Graduate in Medicine, Dental, Veterinary medicine, Alternative medicine, Pharmacy, Nursing, and other paramedical courses with a minimum of 50% aggregate and proficiency in Pharmacovigilance concepts
- Graduate/ Post Graduate from other life sciences with a minimum of 50% aggregate and proficiency in Pharmacovigilance concepts
Preferable skillsets:
- Knowledge in regulatory affairs, ICH- GCP, US-FDA, WHO- GCP Guidelines
- Experience in scientific writings
- Good understanding of medical terms
- An eye for details and keen interpretive skills
- Ability to maintain meticulous records
- Knowledge in software platforms like Argus, Aris G, MedDRA
- Knowledge in post-marketing surveillance methods
- Effective communication.
- Good medical coding knowledge
Employers of Pharmacovigilance
- Pharmaceutical Industries
- Biotechnology Companies
- Medical Devices Companies
- Regulatory agencies such as DCG (I), CDSCO
- PV units in medical colleges and hospitals
- Drug and Poison Information Centers
- Contract Research Organization (CRO), Knowledge Process Outsourcing (KPO), and other outsourcing IT firms.
Duties of a Pharmacovigilance Officer
The duties of a Pharmacovigilance officer (also known as Drug Safety Officer) include
- Collecting and recording the adverse effects of the product received from Health Care Professionals (Doctors, Dentists, Nurses, Pharmacists, and Other Health Workers) and consumers.
- Analyzing the recorded reports
- Writing and reviewing serious adverse effects reports
- Completing the Periodic Safety Update Reports (PSUR) of the product
- Assessing the risk-benefit ratio of the drug
- Informing the reports to the regulatory authorities
- Working on clinical trials of new drugs.
Career path in Pharmacovigilance
- Freshers at entry-level join as Drug Safety Associate (DSA) or Drug Safety Coordinatorwith starting salary from Rs. 20,000 – Rs. 50,000 per month
- DSA candidate with sufficient skills and experience will be promoted to Drug Safety Scientist or Clinical Drug Safety Officerwith salary up to Rs. 1 lakh per month
- Drug Safety Medical Writer or Aggregate Report Writer
- PG diploma or Certification in Pharmacovigilance with a good hands-on experience, backup the candidate to emerge as a Team Leaderwithin a short span.
- Associate Director, Director, or Vice-President
- President
Rius Technology
An effective Pharmacovigilance system is the basic need of every healthcare industry to function smoothly and profitably. Based on the PV report a decision would be taken by the pharmaceutical company/ biotechnology industry whether an action has to be taken to improve the safety of the product or to recall the product from the market. Many high-profile drugs like rofecoxib, nimesulide due to their adverse effects were withdrawn from the market in the recent past; thalidomide, a drug withdrawn after the thalidomide disaster is re-introduced to the market for its effectiveness in leprosy and multiple myeloma. All this is possible only with a robust PV system and skilled Pharmacovigilance professionals.
Considering the above points, we offer to transform the budding graduates to a PV professional. Undoubtedly, our course shall impart the necessary knowledge in Pharmacovigilance proficiency and would make a profound difference in the career of a life science graduate.