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Working as a pharmacovigilance expert

Anna-Leena Saarela is an expert in pharmacovigilance and she sees it as a privilege to work in the front line of this fast developing environment for the benefit of patient safety.

Anna-Leena Saarela is today working as a Pharmacovigilance Expert at Crown CRO, a Finnish CRO with offices in the Nordic and Baltic area and with operations mainly in Europe. She is a part of a team of pharmacovigilance experts and her responsibilities cover a wide range of tasks, from overall maintenance and development of the company’s pharmacovigilance (PV) system, to management and coordination of PV projects and tasks, and daily PV operations, such as safety case processing.

“In this role, no day is the same as the previous one,” she says. “A typical day at work varies depending on the stage of the projects Crown CRO PV are working on at the time. Right now I am involved in developing new Standard Operating Procedures in close collaboration with our Quality Assurance department, while at the same time planning a controlled change to our electronic safety database, Argus Safety, with the system vendor.”

A clinical trial in the start-up phase is also keeping Saarela busy as she and her colleagues are setting up the safety reporting processes for that particular project together with the clinical team and other stakeholders.

“Other daily tasks involve processing and reporting any adverse event reports that may come in from the other ongoing projects and other similar unpredictable tasks,” Saarela adds.

A team effort

Working at a CRO with different customers and projects requires an ability to understand and accommodate the needs and expectations of both customers and regulatory bodies to provide a service that exceeds customer expectations and meets industry standards, Saarela describes. “This makes the job constantly changing and interesting.”

CRO work is a team effort involving communication with customers and authorities but also with various internal stakeholders, as different functions work together to achieve common project goals. “My work involves a lot of meetings, calls with colleagues from different functions, delegating tasks, solving problems, and negotiating with stakeholders to find good solutions. Efficient communication is the key, and I believe any problem can be solved by clear, timely and honest communication with everyone involved,” states Saarela.

In the front line

Anna-Leena Saarela first came to work in the pharmaceutical industry in 2002, as an administrator in clinical trials. “Right away I felt I had found my calling.”

Over the past 17 years she has worked in different companies within the industry as a Language Services Specialist, Project Management Assistant, Clinical Supplies Manager, IxRS and Medication Manager, and now as a Pharmacovigilance Expert at Crown CRO for the past three years.

She started off by studying translation at the University of Helsinki in Finland, and she also has an Authorized Translator’s certificate specialized in medicine and biology. “It was my first job as a medical translator two decades ago that led me to the pharmaceutical industry and clinical trials, and later on I studied further and now I have a Master’s Degree in Pharmacy from the University of Helsinki.”

During her pharmacy studies she specialized in industrial pharmacy, and now she is planning to start PhD studies as a kind of extracurricular activity alongside her day job, she says.

The field of pharmacovigilance caught her interest quite early in her pharmacy studies, as PV was clearly an area where working for the benefit of patient safety was the top priority. “I see it as a privilege to be able to work in the front line of the fast developing pharmacovigilance environment.”

Versatility – a challenge and an opportunity

The best part of her job, Saarela describes, is the versatility. “In a company of this size it is possible to bring out the best competencies in everyone and try your wings in areas you would not have the opportunity to see in a large company, where there may often be less room for movement outside your own role. This job offers a wide range of opportunities for professional growth.”

Versatility is also the most challenging part of the job, she says. Crown CRO is a consulting company aiming to provide its customers excellent service, and when customer expectations vary Saarela and her colleagues have the challenging and exciting role of meeting and exceeding those expectations, while also meeting regulatory expectations in a highly regulated industry. “Every day at the office is different, and part of my job is to adopt new information quickly in a changing environment,” she describes.

Extensive registries and digitalization

The regulatory environment around clinical trials, drug development and marketing is rapidly changing, and staying up to date to  comply with global laws, regulations and guidance is very important for a life science company entering these phases. Both the pharmaceutical industry and the regulatory environment are changing constantly, and the clinical trials field will change with the upcoming adoption of the new EU Clinical Trial Regulation next year, believes Saarela.

“In pharmacovigilance, the adoption of medical device and in-vitro diagnostic device regulations in 2020 and 2022 will have a marked impact on the safety reporting of medical devices and also on clinical trials concerning medical devices overall. Also real world data is a hot topic that will affect the way we look at safety information as well. On a more general level, digitalization is a global phenomenon, which we at Crown CRO see as an opportunity to improve the quality of data and streamline projects.”

Finland is known for its high-standard medical research and a stable industry environment, and this holds true for Finnish CRO services as well, says Saarela. One aspect where Finland especially stands out, even on a global level, she says, is the extensive health databases and registries that will certainly be utilized more and more in future. The registries allow for efficient collection of information, such as real world data.

“Finland is also a forerunner in the adoption of digital solutions, which gives us a stronger position in the midst of global digitalization,” Saarela concludes.