Our Drug Safety Physician has strong medical knowledge and experience in reviewing and analysing adverse events identified during post-marketing surveillance from different sources such as spontaneous, solicited, published scientific literatures and from clinical trials, so that safety signals are identified and investigated in a timely manner, contributing to risks being mitigated well.

PharmZi provide services to the Marketing Authorization Holder with our medical staff in assessing the seriousness and the causality of adverse events and determine if the reported events must be expedited to the regulatory authorities and with their clinical knowledge of the disease and the drug/event combination, the drug safety physician plays a significant part in this case assessment process.

 

The medical staff team involved during preparation various Pharmacovigilance documents for medical assessment but not limited to:

 

• Evaluation of each drug event combination on a case-by-case basis and perform aggregate analysis of similar cases (aggregate reporting such as PSUR/PBRER) to notice a pattern or a causation trend defined as a signal.

 

• Looking at all the undesirable events and see if there is a design or a pattern in the reports. This is called signal detection. In signal detection, the drug safety physician exercises medical knowledge to notice alternative etiologies contributing to the adverse events. If not, the pattern is validated for further assessment.
• Playing an important role in mitigating the risks identified during the drug’s clinical trials and post-marketing period. They become engaged in identifying, implementing, and evaluating such risk minimization methods, which may be required for the approval of the drugs by the regulatory authorities such as the SFDA, USFDA, EMEA, and MHRA.

 

• Providing appropriate medical coding of adverse event and medical term for Medical Dictionary for Regulatory Activities (MedRA).

The role of the role of Drug Safety Physician in the domain of pharmacovigilance is very crucial and significant for evaluation of the safety information identified through various source.