Drug Safety Associate – Key Responsibilities 

Here you can find brief outline of DSA roles  and the source being from understanding of Good Pharmacovigilance practices, FDA guidelines, EMEA guidelines, International Council for Harmonization of Technical Requirement for Pharmaceutical for Human use (ICH) and the Council for International Organization of Medical Sciences (CIOMS).

Once the case is triaged, the Drug Safety professional will complete data entry and further steps include

1.Assessment: 

The Pharmacovigilance professional will perform assessment, from these understandings a case narrative is built up. Assessment need knowledge of PV and include

1. Seriousness assessment: One of the crucial steps in the case processing as it impacts regulatory reporting and product safety. The pharmacovigilance professional will check if the adverse event has one of the seriousness criteria or not. Seriousness is one of the pre-marketed requirements for expedited regulatory reporting and one of the post-marketed requirements for either expedited or regulatory reporting.
2. Causality assessment: A causality assessment is the relationship between the drug treatment and the occurrence of an adverse event. Various approaches have been developed for structural determination of the likelihood of a causal relationship between the drug exposure and the adverse event. It is important for better evaluation of the benefit- harm profile of the drugs, signal detection and to evaluate ADR reports in early warning systems.
3. Label assessment/ Expectedness assessment: As per regulatory authorities an adverse reaction will be unexpected unless it is mentioned in the appropriate Reference Safety Information (RSI) document of the drug. The determination of whether an ADR is or is not expected is not an exact science, there are many grey areas. A decision in many instances will have to be based on clinical evaluation of adequate case information

2.Coding of Adverse events and drugs (MedDRA):

MedDRA is a single standardized international medical dictionary which can be used for regulatory communication and evaluation of data pertaining to medical products for human use. The principle is to be talking the same language across countries, companies and the regulatory bodies. MedDRA coding is a skill and medical judgment has to be made. MedDRA is endorsed by ICH and maintained by MSSO (Maintenance and Support Service Organization).  So, everyone should be trained in MedDRA coding and up to date on the MSSO guidelines.

3.Narrative writing: Drug Safety Associate will build up a case narrative, which is a brief summary of specific events experienced by patients, during the course of a clinical trial/ treatment. Purpose is to conclude causal relationship between the drug and the event through the concise summary. The ICH guideline states that company narratives are requirement for all serious reactions that are submitted expeditiously to any regulatory authority. The case narrative has the comment on the patient background including medical and drug history, the suspicious drug/ medical device, the adverse event eligible for expedited regulatory reporting and the action taken to alleviate and/ or treat the adverse event.

4.Global Regulatory Report Requirements: This topic covers the key components of US and EU legislation, US and EU safety reporting regulations, including publications by the CIOMS and guidelines for ICH. Keeping products on the market without interruption becomes more essential with reduced pipelines of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. The ultimate goal is to ensure rational and safe use of effective medicines in the market.

5.Safety database platform: It is comprehensive pharmacovigilance platform which enables pharmaceutical companies and clinical trial organization to make a faster and better safety decisions, optimize global compliance, case processing, signal detection, detailed analytic, electronic case intake and electronic expedited reporting, risk management, periodic reporting and submissions, as well as the capacity to hold large volumes of cases. There is increased adoption of the safety database platform in various small and large pharmaceutical companies, so learning the basics about the database platform would be helpful for the aspirants to find the job opportunity.

We have discussed a few components related to drug Safety Associate daily job responsibilities, other topics include history of Pharmacovigilance, Life cycle of the drug, adverse event reporting, signaling and risk management.