In a company, not every area of expertise justifies a permanent role, but that does not make it any less important.
A company may need temporary support in pharmacovigilance when workload is increasing suddenly, additional regulatory expertise when variations accumulate or portfolio grows, or a local compliance role such as Responsible Pharmacist in Finland without having enough work for a full-time position. These situations are common, especially in organisations that need to stay lean but still manage their responsibilities properly.
In these cases, the most practical solution is often neither a new hire nor full outsourcing, but experienced support that works closely with the company’s own team.
Why traditional resourcing models do not always solve the problem
When additional support is needed, the usual options are familiar: recruit permanently or outsource the work.
Sometimes a permanent hire is the right solution. The need may however often be too specific, too temporary or too uneven to justify long-term headcount increase. A company may need support during a submission period, an organisational change or a temporary gap in the team. The need is real, but not necessarily permanent.
Full outsourcing can also be the right model in some situations. But in regulated work, companies often want more than a finished deliverable. They want to stay close to decisions, discuss practical choices as the work progresses, and make sure knowledge stays within the organisation. If the work sits too far outside daily operations, that connection can weaken. The final output may be good, but the process can still feel distant.
What embedded expert support means in practice
This is where a more embedded model can work well. An external expert works alongside the client team for a defined period, in a defined role or task area. The company keeps ownership and direction but gains experienced support exactly where it is needed. The work stays connected to the company’s own timelines, systems, products and people.
That can be useful in regulatory affairs, for example, when support is needed with submission coordination, lifecycle maintenance, documentation writing or local regulatory responsibilities. It can also be valuable in pharmacovigilance, where certain responsibilities require continuity, clear oversight and smooth cooperation across functions.
Practical example: Responsible Pharmacist in Finland
A good example of this kind of flexible expert support is the Responsible Pharmacist role in Finland.
For a company that holds a medicinal product wholesale dealer’s licence in Finland, a Responsible Pharmacist is a mandatory role. At the same time, not every company has enough business in Finland to justify a full-time RP position. This is especially relevant when the company has only one or two products on the local market.
This is a good example of a role that is critical from a compliance perspective, but not always large enough to justify permanent local headcount. In that situation, an experienced external expert can be a practical and proportionate solution.
Practical example: Back-up to cover sudden resource gap
When a key person is unexpectedly unavailable, an insourced expert can step in quickly and help keep the work moving. Compared with hiring, the main advantage is speed. There is no recruitment process, no long lead time and less need for basic onboarding. An experienced expert can usually contribute faster, bring working methods from similar situations and reduce pressure on the rest of the team. This also gives the company time to decide more calmly whether the gap is temporary or whether a permanent solution is actually needed.
More than extra hands
The real value of this model is not only additional capacity. The client team is close to the work and decisions can be discussed in real time. Knowledge does not disappear into an external process which means that the company can strengthen its own capability while getting the support it needs.
Because the client team stays close to the work, decisions can be discussed in real time and knowledge stays visible inside the organisation. The company does not just get support; it also strengthens its own capability while the work is being done.
Sometimes a company does not need a large new setup or a major long-term decision. Sometimes it simply needs the right person at the right time, working closely enough with the team to make everyday work easier and more secure. When support is practical, visible and well integrated, it does more than solve an immediate problem. That is often what makes the arrangement worthwhile.
Case example
Global healthcare company & Medfiles: ensuring quality and continuity in post-approval RA and PV activities
Client’s challenge: The client manages a broad portfolio of medicinal products across multiple markets. Overlapping tasks and tight timelines create pressure to maintain quality, reduce errors, and ensure continuity.
Medfiles’ solution: Medfiles provides flexible expert support in regulatory affairs and pharmacovigilance. Support also includes double-checking and back-up resources when needed.
Key benefits: The client is able to manage peak workloads without compromising quality. High volumes of regulatory and pharmacovigilance tasks are handled in parallel, with consistent accuracy and timely delivery. Double-checking reduces the risk of errors, while flexible back-up support ensures that activities continue without delays. This supports ongoing compliance and reliable day-to-day operations.
See also:
- Flexible regulatory outsourcing: choosing the level of support that fits your needs
- Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics
Heta Karvinen, Director, Pharma Regulatory Affairs
Heta Karvinen has worked at Medfiles since 2013. All in all, she has some 15 years of experience from pharmaceutical development, marketing application dossiers and post-approval changes. Before joining Medfiles, Heta was involved in drug product and drug substance development in the pharmaceutical industry.
She has experience from planning pharmaceutical and chemical studies needed for global marketing authorisation applications as well as the regulatory guidelines that govern such studies. Previously at Medfiles, Heta worked as a senior pharmaceutical chemical expert, utilising her skillset in various drug development projects as well as managing quality dossiers for human and veterinary medicines, post-approval variation applications and the studies required to support them. During the years, she has gained valuable expertise from active substance documentation in both the European Union and the United States. In February 2022, Heta was appointed Director of Pharma Regulatory Affairs at Medfiles.
Satu Kujala, Head of Pharmacovigilance
Satu Kujala has worked at Medfiles since 1999 acting in various leadership positions. She is currently serving as Head of the Pharmacovigilance team consisting of 20 experts in Finland and Baltics.
Satu has a Licentiate’s degree in Philosophy (pharmacy), and she has specialised in pharmacology and industrial pharmacy. She graduated from the University of Helsinki. After a short career in the university and pharmacy, she has worked within the pharmaceutical industry for 30 years and has gained diverse experience through working on marketing, quality, wholesale, clinical trials, safety and regulatory tasks. She is familiar with Good Clinical, Pharmacovigilance and Distribution Practices (GCP, GVP and GDP). Acting as EU QPPV for sixteen years has given her deep knowledge and experience of pharmacovigilance systems.
