A Career in Patient Safety: Karina's Journey at ICON

Karina Espinoza's career in pharmacovigilance didn't begin with a grand plan. It started with a practical problem during her final year of a PhD in epidemiology, and it's grown into something she's genuinely passionate about: protecting patients and making clinical trials safer.

Today, as Pharmacovigilance Manager at ICON Mexico, Karina looks back on how she got here, how drug safety has changed over the years, and what it's really like to lead a team when every deadline matters.

Karina's route into clinical research came down to timing and a bit of luck. Whilst finishing her PhD in epidemiology, she had a realisation. "I was thinking, 'Oh my gosh, I don't have work experience. What am I going to do after I finish this?'"

A colleague mentioned pharmacovigilance. Karina hadn't heard much about it. "We didn't know much about it," she admits. "So we started studying the regulations, the requirements, the processes. Everything we needed to understand to actually do the job."

That self-directed learning stuck with her. "I really liked it from the beginning," she says. "It felt like such an important part of clinical research. Taking care of patients, monitoring adverse events, making sure they're safe. That responsibility matters."

She joined ICON in 2008, starting out in safety data management. After a few years, she moved to another CRO, but something brought her back. "When I returned three and a half years later, I noticed changes. New systems, improved e-learning platforms. But the culture still felt familiar."

For Karina, that consistency mattered. "Even with all the growth and change, ICON still felt like a place where people support each other and work well together. That's something that really stands out."

In her current role, Karina manages a team that processes serious adverse event reports from clinical trials worldwide. "Every day, we get information from sites around the world about how patients are reacting to investigational medicines," she explains. "Our job is to assess it, document it properly, and report it accurately and on time."

It's detailed work, and it's heavily regulated. "Authorities ask very specific questions with strict deadlines," she says. "You need to be precise, organised, and ready to respond at any moment. Pharmacovigilance is dynamic. You can't always predict when a case will land on your desk."

What she enjoys most is bringing people together. "I like coordinating teams, helping them understand the process, supporting them when things get tricky." Her epidemiology background gives her a solid technical base, but it's the mentoring side of leadership that energises her now.

"I've been through these situations myself," she says. "I know what it feels like to face a difficult case or a really tight deadline. So I can guide my team with a bit of empathy and some practical advice."

One thing Karina's noticed across different organisations is how ICON's integrated systems make a real difference. "If you take out all the manual steps that exist in other companies and put everything into one system, you reduce the risk of late submissions," she explains. "The way ICON manages safety and regulatory workflows genuinely helps."

She also values the training and development on offer. "There are loads of resources available. Courses in Cornerstone, basic pharmacovigilance training, opportunities to pick up new skills. If you want to grow, the tools are there."

For anyone thinking about a career in this field, she suggests talking to someone who's already doing it. "Ask them what their day actually looks like. What do they enjoy? What's challenging?" She also recommends shadowing. "Seeing how a process works in real life gives you a much clearer picture than just reading about it."

As a manager, Karina focuses on understanding what makes each team member tick. "When I started leading, I made it a priority to get to know everyone properly. Where their skills are, what kind of work they enjoy."

Some people are naturally organised, others excel at analysis or communication. "My role is to match those strengths with the right work, whilst also giving people room to grow." When something complex comes in, she doesn't just assign it. She thinks about who might benefit from the challenge.

"Sometimes I'll put someone forward for a task even if they haven't done it before," she says. "Because I know they've got the potential. And if they need support, we'll find a way. Through mentoring, shadowing, or pairing them with someone more experienced."

She takes real pride in what her team achieves. "When we close a study successfully, meet all our deadlines, and keep the quality high, I feel very proud. It's genuinely rewarding to see the team deliver when the pressure's on."

After more than 15 years in the industry (over a decade of that with ICON), Karina sees her career as an ongoing journey. "Pharmacovigilance keeps evolving," she says. "New technologies, new expectations, new ways of working. You have to stay curious and keep learning."

But one thing hasn't changed: the focus on patients. "Everything we do connects back to someone who's participating in a trial. Our accuracy, our speed, it all impacts patient safety and the integrity of the study."

For anyone considering a career in pharmacovigilance, her advice is straightforward: "Be detail-oriented, be ready to adapt, and be willing to ask questions. This isn't a field where you work it out alone. You grow by learning from others, and by being someone others can learn from too."

At ICON, she's found somewhere that kind of growth actually happens. Where purpose, people and professionalism come together every single day.