Pharmacovigilance Agreements (PVA) Specialist
Tata Consultancy Services Ltd, Mumbai
As per World Health Organization (WHO), Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. It plays a very prominent role in pharmaceutical, biotechnological and other related industries. It basically aims at safety and effectiveness of medications thereby improving patient’s safety and health. The pharmacovigilance market is being expected to be worth a US$6.1 billion by the end of 2020 globally.
The basic educational background for entry level is being postgraduate or graduate degree in bioscience/life sciences generally. In addition to that, candidates undergo training in pharmacovigilance, clinical research etc. after science graduation in order to enter the PV domain. In current scenarios, organizations like TCS, CTS prefer pharma graduates with or without experience in the field in which experience may or may be considered like teaching, clinical research and marketing depending on the requirements. Organizations like IQVIA etc do recruit candidates having master degree in biotechnology with clinical domain knowledge etc.
Now, Lets see the questions asked during interview process.
Let’s be very clear. Interviewer does not want the interviewee to have in depth knowledge about the PV whereas they would like to understand whether candidate is aware about the basics so that candidate understand the terms or study modules during the time of training and thereafter. Basic knowledge includes but not limited to below mentioned points
Definition of PV: Try to answer the definition describing the same in your own words.
Pharmacovigilance is itself vast domain in which basically makes other people aware about one’s experiences on taking/taken one medication starting from first dose. Hence, these experiences was considered as Adverse Events (AE) which medication may or may not affect other body tissues, parts etc other than target. So, in short, PV starts from very preliminary stage of procuring the medication followed by administration and henceforth. PV is collection, detection, assessment and prevention of body’s response to the administered medication.
Importance of PV
PV is important for
Organization who has invented/discovered the medication in order to improve patient’s health thereby establishing the medication is beneficial for patient’s condition [benefit risk profiling]
For the Patient to cure/prevent medical condition in safe and effective way.
Precisely, PV is important for both in their own perspective.
Causality: Definition and importance
Causality is nothing but assessment whether adverse event is caused by the medication or not. It is important to assess the causality which is very essentialto understand relationship of AE with medication required for next level of assessment.
Definition of AE and ADR along difference between the two
There is very minor difference in adverse event (AE) and Adverse Drug Reaction (ADR) / Adverse Drug Event (ADE) is that later is assessed to be caused by the medication.
Adverse Drug Reaction (ADR)/Adverse Drug Reaction (ADE) is a non-intended reaction to the drug occurring with a drug where causal relationship between the event and the drug is found to be positive or established.
Adverse Event (AE) is a non-intended reaction to the drug occurring with a drug where causal relationship between the event and the drug is not known or established.
Therapeutic Areas you worked on along with classification and examples
Therapeutic Areas is basically detailed disease areas like oncology, diabetes, immunology etc. In current project, therapeutic area has worked along with current market trends and other important aspects. Classification and basic physiology of major therapeutic areas like oncology, immunology, diabetes etc.
Serious Adverse Event (SAE/ SAR) /
Seriousness Criteria like death, life threatening etc
Seriousness criteria for AE was set by major regulatory authorities. An adverse event may considered serious based on one or more of the following criteria [WHO]:
results in death, or is life-threatening;
requires inpatient hospitalization or prolongation of existing hospitalization;
results in persistent or significant disability or incapacity;
results in a congenital anomaly (birth defect); or
"medically significant" (i.e., when nothing has been specified and not falling in above criteria. Eg: ‘It was reported that patient took the medication X and had a stroke. No other information is provided’. In this scenario, the event was captured as Stroke with seriousness criteria ‘Medically Significant’ )
Types of Reports received like Clinical, Spontaneous, Initial/Follow-up, etc.
There are Clinical (or solicited) and Spontaneous (or unsolicited).
Clinical Reports are generated from clinical trials or safety related studies under supervision of medical personnel.
A spontaneous report is a report by healthcare professionals or consumers to a company, regulatory authority or other organization describing one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme.
The information can be acquired from various online sources and from regulatory bodies like FDA, EMA, etc websites.
If you wish to study PV and need placements as well for PV, definitely opt for "Certificate Course in Pharmacovigilance" offered by InClinition at Mumbai / Online or at Pune (DY Patil International University) or Nashik or Satara locations.