Working with Stars: Meet Laura Giannini...

Laura is an extremely talented PV professional by all means. She impacts the world around her through how she interacts with others, what she considers being her role, and who she is. It is not only the "what" that matters, is it the "how". Meet Laura...

How did you get into pharmacovigilance?

It was during my pharmacy school internship in a pharma company, I had the opportunity to discover many functions of drug development and discovered drug safety.  My first pharma job was a Product Safety Analyst and while I looked into other roles, PV remained my preference by far.

What has kept you engaged in PV for more than three decades?

I enjoy the operational and organizational-building side of PV while staying connected to new science and technology. It is rewarding to contribute to products being developed and come full circle seeing those products help people around you.

What do you see as one of your most meaningful professional accomplishments?

That there are individuals who I hired in PV as a starting role and those that I have mentored becoming accomplished PV professionals and leaders. It brings me a lot of joy when I bump into them in meetings or we call each other and I have them as my peers now. Also, building a PV function from infancy was challenging and I was so nervous to make mistakes.  It provided a terrific career growth experience and gave me the confidence to try new and innovative approaches.

What surprised you about working in PV?

The variety of expertise needed for a full functioning PV department. Many people think of PV as case processing and reporting, but it is also about identifying safety issues, understanding and preventing problems.  The safety communication and implementation of safety actions can be complex. All these activities require judgment, interpretation, perspective and reasoning, and real-world experience.

What do you enjoy most in your work?

I enjoy building PV organizations from scratch and helping clients develop a compliant and efficient framework based on their current needs but is also scalable. I experienced a lot of safety compliance clean up in my career, and generating for clients a structure and processes which start them off positively brings me a lot of satisfaction.

What values and skills do you credit for your success?

One of the main values is integrity. Even when working in the same area for a long time, one is not always an expert in everything.  Being able to say, I know this, I may not know that, but let's find a solution that is important to me to meet the needs of the client. Also in my PV operations area, strong project management skills, the ability to manage complex information and see the big picture, and an open communication style has served my career well.

What would you change about the PV world?

I would like the strategic contribution of PV to be more broadly respected, especially the importance of thinking early about how clinical safety decisions will affect post-marketing obligations, how to include safety data in submissions, and long-term safety planning. I don't think people realize or fully respect always the strategic aspect of that planning.

What did you want to be as a kid?

A teacher. As I started to enjoy science and later lean to a medical career, my role as pharmacist had a lot to do with educating patients.  Sometimes, part of my consulting role involves educating about what activities PV is responsible for and how PV contributes to the clinical development program that is different from Clinical Development/Medical.

What do you value about consulting and working with JPCC?

There is a lot of freedom and flexibility in consulting, and you can experience a variety of therapeutic areas and novel medicines. I love knowing that there's a group of people at JPCC who are always willing to share their knowledge and experiences to help best serve the situation or solve a question. Having all these different perspectives, I just think is honestly fabulous. I appreciate the ability to offer clients flexible PV support—almost like bringing a PV department to their doorstep—while helping them make decisions they ultimately own.

What do you do after work?

I enjoy golf and yoga and try to be a gardener. I am trying to do things where my brain is used differently than during a workday and have started learning other languages. It is challenging but fun.

What do you want your legacy to be?

To be seen as a connector. Connecting people so that they can achieve their best whether personal or professional. Sharing my knowledge and helping others.

See Laura Giannini profile here.