Drug Safety Associate – Pharmacovigilance As A Career

 

Drug Safety Pharmacovigilance Job as a Career – Eligibility, Salary & Companies Hiring

Similar to engineering and management, the health care sector has also experienced some major changes in the past few years. In earlier times when it comes to the medical sector, people have 2 choices; either they opt for becoming a doctor or they opt for becoming a scientist. Unlike those days, now things have undergone drastic changes. Students from Biology background have multiple segments as an option to build their career in, out of which one of the most trending options is Pharmacovigilance – Career as a Drug Safety Associate.

In our day to day life, many of us have heard that certain drugs have been removed from the market due to its side effects, this is made possible by pharmacovigilance. Drug Safety which is otherwise known as Pharmacovigilance, is a science of studying short and long term effects of medicine on individuals.

Pharmacovigilance has grown considerably as a discipline over the past 10 to 15 years. Because of its huge popularity among young generations, they are choosing their careers in this rapidly emerging & challenging sector as a Drug Safety Associate.

Pharmacovigilance = pharmakon (Greek

for drug) and vigilare (Latin for to keep watch). As the name indicates it basically belongs to the category of pharmacological sciences whose aim is to collect, detect, assess, understand and prevent the adverse effects, in particular, long term and short term effects of therapeutic drugs, devices, and biologics.

Method Of Pharmacovigilance:

• Individual Case Safety Reports
• Clinical Review Of Safety Reports
• Cohort Event Monitoring
• Longitudinal Electronic Patient Reports
• Spontaneous Recording
• Periodic Safety Update Reports (Psur)
• Expedited Report
• Record Linkage

Governing Bodies:

• The Pharmaceutical industry
• Regulatory authorities
• WHO collaborating center for international drug monitoring
• CIOMS (Council For International Organisation of Medical Sciences)

In order to collect information on Adverse Drug Reaction(ADRs), certain centers are also established with the following objectives:

• Improvement in patient care, public health and their safety in relation to medicines.
• Identification of risk factors
• Promoting clinical training and understanding in the field of pharmacovigilance

Responsibilities in Drug Safety Pharmacovigilance Job Profile include:

• Recording and reporting adverse reactions received from healthcare professionals and consumers
• conducting in-depth interviews with patients and healthcare professionals
• developing a thorough knowledge of products
• completing periodic safety update reports on drugs and other treatments
• writing and reviewing serious adverse effects reports and forms
• flagging up early warning signs of adverse effects of drugs
• minimizing the risk of serious side effects
• completing safety audits
• working on clinical trials of new drugs

Employers of Drug Safety Pharmacovigilance Associates:

• Pharmaceutical companies
• Medical device companies
• Biotechnology companies
• Regulatory authorities

Pharmacovigilance offers bright career prospects for all healthcare professionals in terms of career growth and salary. Today a large number of healthcare companies are involved in Pharmacovigilance where one can start their career as PHARMACOVIGILANCE ASSOCIATE OR DRUG SAFETY ASSOCIATE. 

Drug safety associates are Pharma, Life Science, Nursing or Medical Graduates, who specialize in monitoring the adverse effects of drugs in patients and reporting these effects for review and drug modification. Also known as drug safety associates. 

Some of the known profile in Drug Safety Pharmacovigilance Job includes:-

• Drug Safety Associate
• Pharmacovigilance Associate
• Case Processing Expert
• Clinical Safety Scientist
• Safety Associate
• Pharmacovigilance Scientist

Drug Safety Pharmacovigilance experts have numerous responsibilities and this can vary from one company to another. The roles include activities like.

• Processing and writing of adverse event program
• Follow up on important case reports
• Serving as a link between the company and the patients or healthcare experts to provide valid information on product safety.
• Conducting regular pharmacovigilance developments and supervising these processes.
• Attending several meetings related to product safety
• Adding value to any business through product safety functionality.

Today approximately 70+ organizations are present in India which are involved in Pharmacovigilance and have separate Pharmacovigilance units.

People Trained In Pharmacovigilance Can Find Excellent Employment Options In The Following Organizations:

• Pharmaceutical Companies.
• Contract Research Organizations (CROs)
• Biotech companies.
• Specialized Pharmacovigilance centers
• Knowledge Process Outsourcing (KPOs) such as Accenture, Cognizant, Sciformix Corporation, iGATE, etc.
• Regulatory Authorities such as DCG(I), FDA & CDSCO

Top organizations include:

• Novartis
• Parexel
• Dr.Reddy’s
• Aurobindo Pharma
• PPD
• Covance
• ICON
• Accenture
• HCL
• Syneos Health
• INC Research
• KPMG
• Novo Nordisk
• Lupin
• Even Govt organizations have started recruiting for this post of Drug Safety Associate.

Eligibility Criteria:

• The general academic requirement for Drug Safety vacancies are successful graduates with a pharmacy, medical or life science degree, and in some instances further qualifications in project management or a Masters in Drug Safety.
• Drug Safety cases can come in from clinical trials, as well as medicines actively being marketed. Once a side effect is reported in the company database additional to follow up may be required to complete gaps in the case. The completed reports are forwarded to the regulatory authorities for review.
• The initial salary levels are based on academic background, which differs from year to year, as well as from company to company.
• Starting level titles tend to be Drug Safety Associate or Drug Safety Coordinator where the focus is mainly case processing; which involves doing data entry of cases; making sure drug identifiers are captured correctly, and the event reports are detailed enough for the evaluator to decide on the cause of the adverse event.
• Once you have achieved 2-3 years experience you will be skilled in narrative report writing (providing a summary report of events to readers who do not have access to the original data sets, so that the reader is able to come to a conclusion on the adverse event), medical coding using MedDRA (the most commonly used system to achieve a global standardization across regulatory agencies, to code adverse drug reactions) and have a good ICH-GCP understanding. You are likely to apply for roles such as Drug Safety Scientist or Clinical Drug Safety Officer.
• With a good narrative writing background you can move into reviewing and, over time, writing and authoring PSURs (Periodic Safety Update Reports, DSURs (Development Safety Update Reports) and RMPs (Risk Management Plans). With the authoring experience, you can then start exploring roles like Drug Safety Medical Writer or Aggregate Report Writer.
• With 6-8 years of work experience in these positions, you can easily become a Team Lead or Team manager, ultimately achieving the title of Associate Director, Director or Vice-President

Salary…is one thing that no can exactly say firmly how much they get because it varies from job to job and company to company. Mainly it depends on the qualification and job profile which an individual is going to pursue. It also matters the country where u r going to work and also the company where u got the opportunity.

• Pharmacists, Pharmacy, nursing, Ayurveda, homeopathic, dental,  physiotherapy, life sciences graduates are eligible to work in this industry.
• The starting salary for a fresher with PG in Life Sciences, Pharmacy or UG in Pharmacy, Dental Surgery is between 15-25k INR per month.
• For Pharmacovigilance Leadership (with 8–15 years of Pharmacovigilance experience ) the salary varies between 13 Lacs per annum to 40 Lacs per annum depending on education, experience, skillset(s) and company types (CRO, consultancy, BPO, etc)
• Salary package for freshers and experienced associates varies depending on years of experience in the industry they hold.
• Average Life science & pharmacy graduate can easily reach 10 lakhs package in 5-6 years.
• if you are Oracle Argus , Oracle Inform, Clinical , Database administrator, designer , or forms developer related to technical programmer you can expect more than 60k per month, after 5 years u can expect the package of 15 lakhs per year, one can earn equal to clinical SAS Programmer.

So, one thing I can say for sure is – finding a Pharmacovigilance /  Drug safety Associate job is definitely possible. It may take persistence, a lot of work from your part and some couple of months or more, but do not leave hope. This is one such field that is growing and will continue to grow at 10X speed in coming future with a lot of job scope. So its time to be future-ready. Keep an eye on jobs posted at Biotecnika.org & Rasayanika.com.