Pharmacovigilance -Drug Safety Training And Program

DRUG SAFETY MANAGEMENT AND REPORTING

If you are passionate about working as drug safety, patient safety or pharmacovigilance associate with pharmaceutical, clinical research organization (CRO) or research hospital. You must have a bachelor’s or master’s degree in medicine, registered nurse, pharmacy, pharmaceutical or industrial chemistry to qualify. At Qtech-Sol, we strive hard to achieve your career goals and make you successful.

What is Pharmacovigilance ?

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

Drug safety associates need excellent research skills, a strong background in medical or biological science, and in-depth knowledge of the Food and Drug Administration (FDA) and The European Medicines Agency (EMA) pharmacovigilance system and regulations. Your responsibilities include analyzing clinical trial data, writing reports, and determining whether specific pharmaceutical drugs are safe.

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PHARMACOVIGILANCE ROLE (Drug Safety Associate)

A Drug Safety Associate is responsible for assessing the safety of pharmaceuticals drugs once they’re on the market. Using standardised guidelines, they determine whether the medication causes any adverse reactions in patients and report their findings back to the pharmacovigilance department.

Being a significant part of the pharmacovigilance and safety services (PVSS) department, a Drug Safety Associate (DSA) is a key job profile for drug safety management in clinical trials and post marketing surveillance (PMS).

Once a drug has been marketed the work for a DSA begins after. As soon as an alert of a serious adverse event (SAE) is raised the clock starts and sets into motion the necessary tasks that need to be completed to process the events.

In a life-threatening case, or in the case of death, DSAs are given 1-2 business days to process the necessary information and pass it onto other teams. Other medical cases including hospitalisation, significant disability, congenital anomaly or other medically important events require this process to be completed in 2-7 days.

What skills do you need?

The work of a DSA is fundamental to the smooth running of clinical trials and PMS. The role requires resilience, adaptability, excellent time-management and the ability to prioritise and tackle high workloads. To become a drug safety associate, you need a bachelor’s degree in medicine, nursing, or life sciences. Experience working in a medical setting such as a hospital, physician’s office, or pharmacy can make you a competitive candidate for a pharmacovigilance position.

JOB TITLES TO APPLY
Drug Safety Associate(DSA) Local Safety Manager (LSM)
Drug Safety Coordinator (DSC) Patient Safety Manager
Pharmacovigilance Associate (PVA) Medical Reviewer
Drug Safety Case Processor Therapeutic Area Lead