All students who aim at pursuing Pharmacovigilance can seek admission in certificate or diploma courses.
Details of these courses
*Executive Diploma in Clinical Research
*Post Graduate Diploma in Pharmacovigilance
*Executive Diploma in Pharmacovigilance
*Post Graduate Diploma in Clinical Data Management
*Executive Diploma in Clinical Data Management
During these courses, students are imparted with effective training in Pharmacovigilance by expert faculties nationally and internationally, having years of experience
in theory and practical aspects.
Why We Choose Pharmacovigilance as a career option
Pharmacovigilance is regarded as a great career option for interested aspirants as it reflects a well-defined and growing career path. There is a faster career growth leading to managerial as well as director roles eventually along with a quite decent salary package.
Here, in this article, we have highlighted different curriculum and career aspects of Pharmacovigilance. For someone willing to initiate his/her career in Pharmacovigilance, the entry-level job is that of a Drug Safety Associate(DSA). All DSAs get involved in developing various cases, checking for Minimum Safety Information (MSI), reconciliation and then following up processes, along with data entry of all information available in the document and medical coding.
Candidates of pharmacovigilance can pursue both certificate and diploma courses.
*A certificate course in Pharmacovigilance and Pharmacoepidemiology is conducted by Symogen, a KPO, and can be obtained in 4 months. The fee for this course can cost
Rs.50,000 to Rs. 80,000 depending on where you enrol.
*The post graduate diploma programme in Pharmacovigilance is conducted by the Institute of Clinical Research, India. It is a one-year course that costs Rs. 1.3 lakhs.
Training In Pharmacovigilance
You may be eligible for a course in pharmacovigilance, if you are any one of the following:
*Graduate in Pharmacy and Bio-Sciences
*Medical Professional i.e Doctor of all disciplines
*Graduate in pharmacy and bio-sciences
*Junior professional in Pharmaceutical industry, IT Industry and Clinical Research Organisations.
Eligibility Criteria For Pharmacovigilance
For aspirants to undertake a professional career in Pharmacovigilance, the minimum eligibility conditions for applying for the course are as follows:
Graduate or postgraduate degree in Chemistry (subject) with securing at least 50% marks in aggregate;
*Graduate or postgraduate degree in Pharmacy or Pharmaceutical Sciences
*Graduate or postgraduate degree in Medicine
The process of selection for the course is completely based on merit. Students are granted admission only if they have cleared a written examination followed by a personal interview.
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Required Skillset For Pharmacovigilance
For any aspiring candidate to specialize and become DSS (Drug Safety Scientist), one needs to have the following skillset;
- Knowledge of Medical coding
- Narrative and Scientific writing
- Good understanding of medical terms
- Basic knowledge of regulatory affairs, ICH-GCP, and other compliances
- An eye for detail
- Ability to maintain meticulous records
- Excellent analytical & problem-solving skills
- Effective Communication
- Systematic Approach to Tasks
- Good interpretive skills
Salary & Job Prospects In Pharmacovigilance
For Pharmacovigilance professionals, typical monthly salary ranges from Rs. 50,000 to Rs. 1,50,000 per month. The starting salary may approximately be Rs. 35,000 to Rs. 50,000 per month for Medical candidates.
For highly ambitious students, it is important to know that having a Post Graduate Diploma degree in Pharmacovigilance along with an overall experience of 7 to 8 years in this position, is just enough for you to become a Team Lead in a very short period in any organization. Undoubtedly, one can make his/her successful career in the field of Pharmacovigilance. With an increased focus on drug safety all across the globe, the volume of jobs in India will also rise in this field. As concerned with future forecasting, there would be ample job opportunities in this field with the ever-increasing demand for Pharmacovigilance practitioners. Students will be recruited in various pharmaceutical companies at attractive salary packages. With the invention of new drugs every day, the career prospects in Pharmacovigilance look exceptionally well.
Top Recruiters In Pharmacovigilance Course
Presently, top pharmaceutical companies such as CROs, KPOs, IT firms, and consulting firms are the important ones that offer Pharmacovigilance positions in bulk as jobs in the Indian market.
Students trained in Pharmacovigilance would find potential job opportunities in the following sectors:
* Pharmaceutical Companies, either MNCs or Indian & Biotech companies * Clinical Research Institutes * KPOs such as Accenture, Quintiles, etc. * Regulatory Agencies such as DCG (I) & CDSCO * Pharmacovigilance units within Medical colleges & Hospitals
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Pharmacovigilance – Should I Outsource? And to Whom?
The laws governing pharmacovigilance lay down strict instructions on what pharmaceutical companies must do in the event of detecting a serious adverse event, and indeed what constitutes a serious adverse event. With these major demands on pharmaceutical companies, it is important for them to set up an appropriate pharmacovigilance system, and this causes a number of problems.
First of all, the regulations are often hard to interpret certainly when it comes down to the finer points.
Second of all, if you get it wrong, you can be subject to a pharmacovigilance inspection, and you may eventually have your marketing authorization revoked for a particular product.
So, there is an awful lot riding on having effective pharmacovigilance solutions to hand. As a pharmaceutical company, you basically have two choices: either do the whole lot in-house or outsource some or all of your pharmacovigilance operation.
There are pros and cons to both.
Pros – Inevitably, in-house wages will be lower than using qualified staff. In-house staff already know the company culture and systems and will adapt quickly to running and working in a pharmacovigilance department. Where you have marketing authorization for many products in many territories it makes sense to have dedicated staff to deal with drug safety where a smaller company might be better off outsourcing their pharmacovigilance operation.
Cons – You need specialist staff in pharmacovigilance. You can get training, but where and at what cost? You will need a pharmacovigilance database that is validated, not just a spreadsheet in Excel or some Web site the CEOs kid knocked up in Access.
Then there’s the training – pharmacovigilance training. Would you like your staff trained by academics who don’t really understand the industry? Or maybe they should be trained by former regulators who have never had to work in a pharmaceutical company so their knowledge is only theoretical? Or maybe you could have them trained by someone who used to work for a pharmaceutical company who will have no real idea about what the regulators are thinking.
Or possibly you could find someone who has experience of all three arenas who could train your staff, someone accepted as a registered presenter for Continuous Professional Development by the CPD Certification Service. Such people are out there but would be hard to find. When you look at the qualifications of the people doing the training at pharmacovigilance conferences and in-house, these are the sorts of factors that should influence your decision to attend – do the presenters have the right experience so that my staff and I will learn what we need to in these sessions?