Interpersonal skills during audits and inspections…

Until now, I have used this blog to report on changes in the requirements applicable to Pharmacovigilance. This time is different and I would like to share the learning I took from a project I am involved with.

The story starts in the summer of 2017 when I received a call from a contact in the Global Pharmacovigilance group at Bayer. This contact knew me as a Pharmacovigilance Auditor and asked whether I would be interested to work on a coaching module. This module was part of a training programme the company was putting together to make people better prepared for Pharmacovigilance Audits and Inspections.

The Coaching Concept

One of the requirements was that I partner with another consultant that Bayer had identified for the project: A stage actress also working as a personal coach… How interesting !!

This is how I met Karin Seven, who has been working with professionals in the pharmaceutical industry for more than 20 years, helping them increase the impact of the messages they want to deliver during the course of their professional life.

Based on the requirements and objectives set by Bayer, we developed a concept for a full-day of individualised training following a standard agenda:

• During a baseline Mock Interview, I would cover topics relevant to each student in the same manner as I would do during a real audit, while Karin observed.
• Following an assessment review, we would then collectively discuss the strengths and weaknesses of the student, from both the content and behavioral perspective.
• Based on the assessment, Karin would work with the student through various exercises tailored to the individual’s needs, while I would review the documents requested during the Mock Interview. The exercises proposed by Karin are intended to help correct a range of personal habits that can include posture, breathing and voice coaching.
• I would then lead a second Mock Interview, providing the student the opportunity to put the lessons learnt into practice.

Examples of behavior to avoid…

Before I provide my feedback on this experience, I thought I would share a few examples of behaviors we sometimes see during audits and inspections, and which I DO NOT recommend:

• Appear disinterested and avoid eye contact
• Overuse filler words, e.g. “Humm” every two words
• Make an effort to refute any opportunity to cooperate in the audit/inspection process
• Talk with an inaudible voice that can be covered by the noise of the air-conditioning system
• Respond to questions with answers as long as possible, with a monotone voice and as fast as possible so there is little chance for anyone to take accurate notes
• Start answering before the auditor/inspector finished his/her question
• Start the interview with a lengthy PowerPoint presentation to waste time
• Act in such a way that the auditor/inspector feels like a pupil being taught a lesson…

The benefits of our Coaching Module

I am most impressed with the changes I can sometimes measure between the initial and the second Mock Interview. It is true that a few of our students did not really need much help, as they were already visibly confident in their responses but for others, I was amazed to see how much progress they made as a result of the coaching session. Instead of looking shy or confused, they managed to make slight behavioral changes that made their message much more impactful. They became more interesting to listen to, more self-confident and more convincing.

From an auditor’s perspective, it is of course clear that it will not be sufficient to deliver your message in a pleasant way if the content does not meet the expectations. We are trained to rely on evidence to assess compliance and you will not be able to hide the reality of a poor Pharmacovigilance System just by providing responses in a confident and decisive manner. However, clear and articulate responses delivered with confidence and ownership can only make the interview process more efficient and interesting for all those involved.

My part was rather easy: I just helped students become more familiar with the type of questions they may face during actual Pharmacovigilance Audits and Inspections. In my view, the coaching provided by Karin helped many of the students deliver their message in a more convincing manner. Even though this may not improve dramatically the outcome of an audit or inspection, I am convinced that the changes I have witnessed with some people will have a great impact for them, not only in their professional but also in their personal life if they choose so.

What’s your take on this ?

Please feel free to use the comment field at the bottom of this post to share your experience or comments. I am particularly curious to hear from my colleagues, Auditors and Inspectors…

Many thanks in advance !

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Thierry Hamard (LinkedIn Profile) is a Pharmacist with more than 15 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PV Focus was established in 2004.

Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.

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Karin Seven is working as a Coach and Trainer for more then 22 years. She is a qualified actress, working on stage for more than 30 years as actress or director.

Her expertise covers performance skill including speech, body language, posture, mindsets and radiance.

She is also the author of the book PowerAct - Deliver your best Performance, which is published in German by Haufe.