Drug Safety Physician.
Medically-trained pharmacovigilance support.

What is a Drug Safety Physician?

Drug Safety Physicians must fulfil a skilled requirement to have both a strong medical knowledge background and pharmacovigilance experience, alongside good analytical and communication skills. They work across Clinical and Post-marketing settings to manage the Benefit-Risk safety profile of medical products.

They are required to inspect, assess, and take action based on a wide array of data and regulatory resources. This includes the examination of ICSR Case Reports, PSUR/PBRERs, adherence to regulatory guidelines, analysis of clinical and post-marketing trial data, in-depth exploration of safety signals, and consideration of any additional information that could influence the safety profile of a pharmaceutical product.

Consequently, they play a crucial role in shaping and maintaining Risk Management Plans (RMPs) and are instrumental in the development and upkeep of Risk Evaluation and Mitigation Strategies (REMS).

Click here for more information from the EMA on Safety Signals, and  Signal Management.

Click here for more information from the EMA on Benefit-Risk Management.

How Aegisana’s Drug Safety Physician services can support you?

Expert medical assessment.

Aegisana’s Pharmacovigilance team exclusively collaborates with proficient, medically trained Drug Safety Physicians capable of supporting a diverse range of tasks. These include the evaluation of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) in clinical trials, as well as the analysis of Individual Case Safety Reports (ICSRs) in post-marketing contexts.

They also work with all signal and benefit-risk management documentation, including signal reporting, aggregate safety reports, risk management plans, and risk minimization measures

A holistic approach.

Additionally, we can customize RMPs and REMS to fit the specific needs of local authorities and situations. For example, this may involve addressing safety concerns for a prominent population or adapting RMPs to local languages or formats.

Our principal objective, as always, is to foster trust and confidence in our services. Managing Benefit-Risk and creating compliant and authoritative RMPs and REMS is one more way through which we aim to achieve this.

Our focus remains on safeguarding the well-being of your patients, ensuring the safety of your products, and confirming that you’ve made the right choice in partnering with us for pharmacovigilance services.