Drug Safety Associate Interview Preparation Guide

Everyone should learn from his mistake. I always try to consult my mistakes with my kith and kin especially with elderly and experienced person.
I enrolled myself into a course useful for the next version of our current project. I attended seminars on personal development and managerial skills improvement.

Working with the team to develop them – I am keen that my team should be recognised not only for their safety expertise but the other skills and experience that they can bring to the business outside of safety.
I also enjoy looking at how we can make our processes more efficient so that we can create more time for proactive risk management and activities which focus on using safety data to maximise patient safety.

This is a very common question that is asked in almost every interview. I love this question because it gives you the opportunity to sell yourself. Discuss what makes you standout from the crowd and show them how you can help advance their company. Remember to be specific. This is where all the company research you have done comes into play. You should have an idea as to why the company is hiring or looking to hire someone for that position. What problem do they have that they are looking for people to help them solve. And once you can establish this, you are to show them how you can solve this problem for them.

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Volume 9A brings together general guidance on the requirements, procedures, roles and activities in the field of pharmacovigilance, for both Marketing Authorisation Holders (MAH) and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH).

If an event is associated with any one of the following, it is considered to be serious

☛ Death
☛ Life threatening
☛ Hospitalization or prolongation of hospitalization.
☛ Congenital anomaly
☛ Disability
☛ Medically significant

Two types.
1. Active PV and
2. Passive PV

☛ Active PV: Active (or proactive) safety surveillance means that active measures are taken to detect adverse events. This is managed by active follow-up after treatment and the events may be detected by asking patients directly or screening patient records. The most comprehensive method is cohort event monitoring (CEM)

☛ Passive PV: Passive surveillance means that no active measures are taken to look for adverse effects other than the encouragement of health professionals and others to report safety concerns. Reporting is dependent on the initiative and motivation of the potential reporters. This is the most common form of pharmacovigilance. It is commonly referred to as “spontaneous” or “voluntary” reporting.

If you are being asked this question from your employer then you can explain your experience. Tell the employer what responsibilities you were performing during your job. You can tell what programs you developed and what modules you worked on. What were your achievements regarding different programs.

The reason why you are asked this question is to hear what you consider difficult and how you approached the situation. Select a difficult work situation, which was not caused by you and can be explained in a few sentences. You can then show yourself in a positive light by explaining how you handled the situation.

System Organ Class (SOC)

High Level Group Term (HLGT)

High Level Term (HLT)

Preferred Term (PT)

Lower Level Term (LLT)