Drug Safety Physician service.
What is a Drug Safety Physician and what do they do?
Drug Safety Physicians are experienced pharmacovigilance professionals who can manage the benefit-risk safety profile of medical products, and have a strong medical knowledge combined with analysis and communication skills. They work in both the Clinical and Post-marketing scenarios.
Typically they will need to analyse, evaluate and act on a range of data and regulatory sources including ICSR Case Reports, PSUR/PBRERs, regulatory guidelines, clinical and post-marketing trial and study data, Safety Signal analysis and any other source that can affect the drug safety profile.
They will therefore be a key part of, or be responsible for, the creation and update of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
How our Drug Safety Physician service can support you.
Our Drug Safety Physicians are here to support you with the varied tasks that need or benefit from experienced, medically trained, pharmacovigilance personnel.
These activities span a full range, from medical review of SAEs & SUSARs in clinical trials and ICSRs in post marketing, to reviews of signal and benefit-risk management documentation including signal reports, aggregate safety reports, risk management plans and risk minimization measures.
Our experts can also fully assess all screened information to identify any impacts on patient safety, or anything that may require further investigation or changes in specific markets.
What our clients say about us.
Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.