If you are a fresher and looking for a job in Pharmacovigilance, you need to know what really happens in a Pharmacovigilance department. Learn here in detail about various sections where you will be working. When you hear about Pharmacovigilance, it is like an umbrella with many subsections in it and every section is linked to each other. Here is a list of various departments within Pharmacovigilance
- Case Processing
- Medical Writing or Aggregate Report
- Signal detection
- Pharmacovigilance Agreements or SDEA
- Pharmacovigilance System Master File or PSMFs
- Regulatory intelligence
- Literature search
- Risk Management Plans
We will discuss about case processing in details. Rest of the sections will be discussed in other articles.
What is case processing in Pharmacovigilance?
Whenever a patient or their health care provider reports an adverse event, it comes to pharmacovigilance department as a source document. This is also called as Individual case safety reports or ICSRs. Lets go step by step
- Data Collection: There are call centers or Pharmacovigilance mail box where patient reports adverse events and details of the same are collected. This information is sent to processing centres.
- Triage: This is the first step in case processing. During triage, all four valid elements also known as PERD are verified. If any of these elements are missing the case cannot be processed further. When all elements are identified it goes further into case creating in safety database.
- Data entry in safety database. A drug safety associate first do duplicate searches to identify if the information received is a new ICSR or a follow-up to existing ICSRs. DSA then enters all the information present in the ICSR in safety database and writes a case narrative describing the summary of entire report. It takes 0.5hrs to 2hrs depending upon the information present in the case. When you apply for case processing job, you will be doing this process. This data entry is not just a normal data entry, it requires pharma knowledge. The product and the adverse events need to be coded properly with the use of inbuild product dictionary as well as MedDRA. Once the case is entered in safety database it is then moved to next workflow which is quality review.
- Quality review: A drug safety quality reviewer then reviews the information entered in safety database. Based on the source document, they verify if all the information entered is correct. If incorrect, it is marked as an error in QC error sheet. A feedback is given to the DSA who entered the information in safety database.
- Medical review: The next step is medical review: A medical reviewed who is MBBS doctors, assess the labelling and causality of the case. Labelling assessment means whether the adverse event is a new information or information about the occurrence of the adverse event was already mentioned in the package inserts or product information. They then assess the causality which means whether the adverse event is related to suspected medicine or not. There are various methods and scales for assessment of causality of which WHO Causality scale is widely used.
- Submission: Once the case is medically reviewed it goes for submission to the submission team. The submission team then assess the requirement of each country and analyse to which country’s health authority this case will be submitted. If any of the ICSR is missed to be submitted to health authorities, the health authorities gives major observation during inspection. It is a critical step in Pharmacovigilance. Every month compliances are checked whether all ICSRs were submitted and within 15 calendar days or not. 15 day means 15 day it should not be 16th day or else it comes under non compliance as per health authorities.
Sources of ICSRs
You have already seen what happens step by step in case processing. Now we will see from where the source information is received regarding adverse events.
- Call Centers: Whenever any patient experience any adverse event, they call to the call centers of Pharmaceutical companies where they report all adverse event information. The call centers have protocols where they ask for all the details required to fulfill validity of cases. In case they need more information, they do follow-up call to the patients. These type of adverse event reports received directly from consumers are called Spontaneous reports. These reports hold more value in Pharmacovigilance.
- Emails: Many patients or their HCP report adverse event details to the emails provided by pharmaceutical company to report adverse events. If the information is incomplete, follow-ups are done to get additional information. These are also know as spontaneous reports.
- Sales Representative: When sales representatives visits doctors, the doctors reports adverse events. The sales representatives are trained to collect information on adverse events. These type of report also comes under Spontaneous reports.
- Reports from Health Authorities: Some patients directly report to health authorities to respective countries. So Health authorities redirect these reports to the manufacturer of these medicines. Many health authorities have programs like Medwatch reporting USA, Yellow card in UK where it is simpler to report adverse events to authorities.
- Literature reports: In all pharmacovigilance guideline, it is requirement by health authorities to do literature searches to get more safety information about their medicines. This is the highest volume of the total ICSRs processed in safety database by a Pharmaceutical company. There are databases like Embase and PubMed that are searched to find literature ICSRs. There are teams to do this activities.
As a fresher when you are going for a case processing interview, you will find a best overview of what actually happens in a Pharmacovigilance or drug safety department in a case processing team.
Some terminologies to refer
IRD: It means Initial Receipt Date. The is the date when an adverse event was first received by any representative of a pharmaceutical company. It can be call center executive or sales representative or even the watchman of a Pharma company. So they all are trained to collect adverse event report or atleast to direct it to correct department.
Reconciliation: A drug safety associates send email to all the partners and sales representatives from where adverse events are received, this activity ensures that no adverse events were missed during a particular period.
Seriousness of event: An adverse event is classified as serious if it requires hospitalisation or disability or it is significant medically. Or else it is considered non-serious
This is a high level overview of case processing. All Drug safety associates work on timelines and they have to do all the above mentioned activity within 15 calendar days. So there is large scope for case processing but work load is also high here. So chose you career path accordingly.