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What does those involved in pharmacovigilance and clinical safety do?

I like to think of pharmacovigilance and clinical safety as the most human and empathetic aspect of pharmaceutical field. This is the reason for which I love this job.

Pharmacovigilance and clinical safety are, to use a metaphor, the hidden actors of clinical research that act in silence in order to monitor the risk benefit ratio of a drug or a vaccine.

The pharmacovigilance system has to be organized according to specific guidelines (Good Pharmacovigilance Practics (GVP)) in order to obtain, effectively and efficently, information regarding the safety of the product from various sources: clinical trials, observational trials, scientific literature, health professionals, patients, media, ecc.

This is a methodical work, done according to working instructions and standard operating procedures (WIs and SOPs).

Each individual case safety report (ICSR) is tracked and entered in a safety database. And each update of the database is registered and tracked.

 All the ICSRs are assessed by a physician through a clinical evaluation; adverse reaction, medical history and concomitant disease are codified by the MedDRA coding. Also the drugs and the lab data are codified.

Depending his characteristics, a ICSR should be submitted, if required and in a timely manner, to Regulatory Authorities and/or License Partners.

In addition to the ICSR evaluation, the pharmacovigilance and clinical safety department has the charming obligation to write the aggregate reports: the Periodic Safety Update Reports (PSURs) for the post-marketing products and Development Safety Update Reports (DSURs) for the drugs in phases I-III.

Another important and charming task of the department of pharmacovigilance and clinical safety is the signal detection.

The first step of the signal detection is the analysis of summary tabulations of adverse reactions in order to catch a signal.

Then the signal, if detected, should be validated and confirmed through the study of the biological plausibility (done with the literature screening), statistical calculations and database searching with, for example, the use of the Standardised MedDRA Queries (SMQs).

The aggregate reports (PSUR and DSUR) and signal detection are solid tools to study the evolution of risk benefit ratio of a drug or vaccine.

The signal confirmation leads to the change of the risk benefit ratio and to the update of the Risk Management Plan (RMP).

The aim of a Risk Management Plan is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks.

It is an alive document that changes with the life of the product and its risk benfit ratio update.

All information regarding the safety of the product are written in the reference documents that are the Company Core Data Sheet (CCDS) and the Summary of Products Characteristics (SMPs) for post-marketing and the Investigator Brochure (IB) for clinical trials.

This is the reference documentation for physicians and Investigators.

During clinical studies, the clinical safety personnel is involved in: writing Safety Management Plans (that describes the tasks and the responsibilities of investigators, sponsor and clinical safety department), reconciliation between pharmacovigilance database and clinical safety database, writing and review of the study protocols, update of IB, and writing and review of DSURs.

The Pharmacovigilance System is a net of documentation mutually linked.

This net should be managed through a quality system that ensures its quality (quality assurance).

The quality assurance has numerous tools as the SOPs, the WIs, the Key Performance Indicators (KPIs), the Corrective and Preventive Actions (CAPAs), the audits (internal and esternal), the personnel training, the tracking logs and the system validation.

The Company has the obligation to mantain a Pharmacovigilance System Master File (PSMF) that describes the system, how it works and all the partners and external functions involved.

The Pharmacovigilance and Clinical Safety Scientist and the Qualified Person for Pharmacovigilance are skilled puppeeters that pull the strings of this well-organised scenario and make sure that nothing escapes and everything is achieved according to the right time and quality.


Patrizia Secreti is a pharmacovigilance scientist passionate of clinical research and medical writing. At the time, she is a Freelance Pharmacovigilance Consultant and owner of a drug store.

She is a healthcare and scientific blogger for passion.

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