An expert says “A career in Pharmacovigilance is exciting with a well-defined career path. The growth is fast which eventually leads to managerial and director roles with good pay packages”.
What is Pharmacovigilance?
Abbreviated as PV or PhV, Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. Generally speaking, it is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological, herbalism and traditional medicines with a view to:
- Identifying new information about hazards associated with medicines
- Preventing harm to the patients.
Why should students opt for Pharmacovigilance as their career options?
Pharmacovigilance is a great career option for life science and pharmacy graduates. It is a scientific discipline that is primarily concerned with reporting and analyzing of drug side effects. It is primarily due to the work of Pharmacovigilance professionals that the drugs in the market that we consume are mostly safe and those that are found harmful are taken off the market. Pharmacovigilance professionals continuously monitor the safety of the drugs in clinical trials as well as the drugs already being sold in the market. After a drug side effect is reported, the Pharmacovigilance professionals enter the event in relevant databases, follow up with the case to gather more information and forward these reports to regulatory authorities and other applicable bodies. The Pharmacovigilance professionals identify signals in data that may point towards a potential side effect and probe the case further.
How has the sector fared so far?
Setting up of stringent laws by regulatory bodies (e.g. US-FDA, DCGI, EMEA etc.) has led to the adoption of a systematic Pharmacovigilance framework worldwide. This in turn had led to the creation of large number of Jobs pertaining to this field.
Worth of Pharmacovigilance market worldwide was US $186 million in 2008 and is estimated to reach US $ 2,253 by the year 2015.
At present, India is the fourth largest producer of pharmaceuticals in the world and therefore is a surfeit of drug brands with more than 6,000 licensed drug manufacturers and over 60,000 branded formulations. India offers unique advantages for the growth of Pharmacovigilance that include:
- Rapid induction of New Chemical Entities (NCEs) and high technology pharmaceutical products in market.
- Abundance of patients with genetic diversity
- Presence of Lakhs of formulation in domestic market
- Presence of large number of licensed drug manufacturers in India
- Potentially large world scale Adverse Drug Reaction (ADR) database
A Pharmacovigilance professional does the following:
- Track all adverse event reports received and completed;
- Review and assess all source documents, and compile data in an adverse event report;
- Data enter report into the safety database;
- Code adverse events in the safety database;
- Narrate the case information in the specified format
- Perform labeling assessment of adverse events, comparing adverse event to adverse events previously reported and contained in the product label;
- Release report to safety database
Starting salaries for freshers are substantially a function of their educational background, varying from year to year as well as across organizations and domains. The following represents the typical work place hierarchy.
- The Entry level Job for life science graduate is DSA (Drug Safety Associate). DSAs are mainly involved in case creation, checking for MSI ( Minimum safety information – a patient, a reporter, a suspect drug and an adverse event ), reconciliation and follow-up process, data entry of all
information available in the document and medical coding
- Once an individual acquires an experience of 2-3 years in that position and builds the required skill sets (Medical coding, narrative and scientific writing, good understanding of medical terms and basic understanding of regulatory affairs, ICH-GCP and compliance etc.) he can go on to become a DSS (Drug Safety Scientist).
- Individuals once having acquired a good narrative writing experience can pursue it on a larger frame, moving from individual cases like writing for PSUR(Periodic Safety Update Report) and PADER(Periodic Adverse Drug Experience Reports) and as well as becoming an Aggregate report scientist.
- With an overall of 7-10 years’ experience in this position individuals can easily become a Team lead or Team manager based on the company.
- Lastly, individuals end up acquiring the position of a Director or Vice-President with an experience of 9-10 years.
- Fresher: Rs. 15,000 – 20,000
- After 5 years: Rs. 50,000 – 60,000
- After 10 years: More than Rs. 80,000 – 90,000
Individuals trained in Pharmacovigilance will find good Job options in the following sectors:
- Pharmaceutical Companies (MNCs & Indian) & Biotech Companies.
- Clinical Research Organizations.
- KPOs like Accenture, TCS, CTS, WIPRO & SATYAM.
- Regulatory Agencies like DCG (I) & CDSCO
- Pharmacovigilance units in Medical colleges & Hospitals
Besides this, students might land up in Companies like:
Asian clinical trials serene, Bioserve, Clin invent, Clintec international, Clinigene, Dr Reddy’s lab, Elly Lilly, Glaxosmithkline, IGATE clinical research, Intass biopharmaceuticals, Johnson & Johnson, Lambda therapeutic research, Lupin limited, Matrix laboratories ltd., Merck, Novartis, Novo Nordisk, Pfizer, Pharmanet, Quintiles, Ranbaxy, Roche India, Sristek, SiroClinpharma, Synchron, Sanofi Aventis, Torrent pharma, Vimta labs, Zydus, Reliance life science, Amed, Accutest, Actimus, Adroit insights, Alembic, Asian Clinical Trials and many.
XERTZ Solutions is the right option as the Lead Trainer has the expertise of handling multiple projects including US and EU submissions. Above all, XERTZ aimed to deliver the best quality and retain the Market value.
Certified Pharmacovigilance Professional:
Highlights of XERTZ Pharmacovigilance Training & Certification includes, but not limited to…
- Starts with basic Anatomy, Physiology and Pathology Training
- Global Pharmacovigilance Industry Overview and Role of Drug Safety Team
- Pharmacovigilance Terminologies and guidelines
- Source of Information
- ICSR Processing and Reporting
- Aggregate Report preparation and Reporting
- Literature Search
- MedDRA/WHO DD Coding
- Narrative writing
- Special case scenarios Training includes legal, medication error, Overdose, Pregnancy, Drug Interaction, Secondary exposure, Off-label use, Lack of drug effect, etc.
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