Robust relationships are integral to managing pharmacovigilance (PV) in diverse markets, where global strategy does not always meet local needs.
During the webinar Navigating Local Pharmacovigilance Obligations in a Global Landscape, experts from large and mid-sized pharmaceutical companies emphasized the importance of building helpful and rewarding relationships between global and local.
It was noted that while process harmonization across the organization is the goal, countries can have their own requirements. These need to be acknowledged and supported, as a one-size-fits-all approach is not always possible.
Fostering a culture of inclusion is key to enabling local teams to feel valued and empowered to contribute to the different global strategies.
As our experience has shown, it is important from a global standpoint to show some flexibility to accommodate these regional requirements. One way to achieve this is to have regional coordinators, who liaise between the global team and the local function.
Opening communication channels
Effective communication is critical to ensuring alignment between local and global operations and it is very much a two-way street.
Global teams must clearly outline current priorities, as well as what is on the horizon, so that local experts not only feel involved but can provide feedback and valuable input from the local perspective. The local PV expert, on the other hand, needs to keep global informed about any issues the affiliate might be having.
“Headquarters can provide the framework to ensure everything that can be done at the global level is carried out,” one of the speakers said. “But affiliates should be proactive about providing global with what they need and what they think we in global should know.”
The level of communication can depend on the nature of the relationship, too. Another speaker said factors such as language barriers, regulations, and experience could influence the amount of support for local affiliates, including increasing communication.
“Sometimes the person might be more junior than in other countries or the country is new and needs more support,” the expert noted.
Conversely, companies may identify lower-risk regions that can operate with more autonomy, though some products will require more direct oversight no matter the market.
In our experience, it is essential to implement a risk-based approach or risk-based oversight, taking advantage of the compliance and audit results to determine the autonomy that a local team should have.
As we have found, it can be challenging when scaling up projects to ensure communication is standardized to all the local teams. Having a robust communication planning base is key to making sure that the message is conveyed across all functions.
Collaborating for patient safety
With so many pieces, or functions, to a PV program, collaboration is an integral part of successful communication. This means fostering relationships between local functions that will, in turn, strengthen the global partnership.
While PV experience is the top priority, the local affiliate should also have a good understanding of other key functions and be able to communicate with them for the benefit of all. While this increases broader knowledge on the ground, it also improves feedback to and from global, including in areas such as:
- Medical – For example, guiding implementation at the local level of global safety information initiatives.
- Regulatory – Keeping global informed of local regulatory changes that could affect future compliance.
- Data and digital – Ensuring local experts are informed of global initiatives.
PV also needs to connect with functions such as commercial or market access, as they often affect interaction with patients and healthcare professionals and must be aligned from a safety perspective.
“If we don’t talk to each other, we can’t make sure the patients are kept safe,” one of the speakers said. “If we are not letting the other functions know what we need from the PV side, or the other functions are not letting us know what they are planning in their daily business, it affects patients.”
Finding the right tools
While keeping affiliates informed of global news or changes is an important part of relationship building, companies need to ensure the way they communicate is appropriate for the target market.
Experience shows that too many emails or other forms of communication can overload team members and risk important messages being lost in the volume.
Mindful of the amount of work affiliates have on their plate, one expert said she tried to keep daily communication to a minimum. “I have a weekly email from the global team, where everything that happened that week that might be relevant to them is shared, as well as the actions,” she said. “It gives that oversight of everything that was important or relevant, so they don’t need to worry if they miss an email or not.”
Another speaker concurred, noting that it is important to allocate time in team meetings to share news and to allow people time to discuss how it might impact them.
“It should be a mutual relationship, ensuring the stakeholders at the country level are really listened to and heard, and that requires contributions from both sides,” she said.
Another way to keep teams informed is through platforms such as SharePoint, where team members can have access to important resources, sharing the latest news, and creating transparency.
Allowing room to grow and move
Global companies that encourage professional growth and regularly offer such opportunities for local affiliates also set the groundwork for better engagement.
Aside from providing suitable programs and resources, global needs to demonstrate investment in what is happening at the local level. This includes ensuring company representatives attend relevant industry events and focus on local PV activities, as well as encouraging affiliates to connect with other colleagues and take every opportunity to learn.
The better understanding companies have of the strengths of local affiliates, the more able they are to align them with strategic priorities. With the right skillset and guidance, one speaker noted, locals can even become the ‘voice’ for global.
“We have a collaboration hub where global teams can request resources from affiliates,” another speaker noted. “For example, if we need someone two hours a month for the next six months for a project, we ask for volunteers.”
Alternatively, global can suggest projects that might suit local expertise, or present a learning opportunity to continue professional development. “By knowing people well at the local level, we can steer them to projects so that they get experience working on global initiatives, as well as giving them a voice.”
Communication is central to every good relationship, particularly where the cost of not establishing clear pathways for collaboration is so high.
It is important that global companies accept that one size does not fit all and that they work with local affiliates to ensure the integrity of PV is maintained. This may mean allowing a little freedom to make changes that best suit the market, without compromising safety.
By creating platforms for open and honest dialogue with local functions and fostering a culture of inclusion, companies show their willingness to build a relationship where everyone feels they are on the same path – working to improve the lives of patients everywhere.
About the author:
José Miguel Rivas Romero is Program Manager, Service Line Lead for local pharmacovigilance and pharmacovigilance expert at PharmaLex, a Cencora company. José Miguel has more than 10 years of experience in the pharmaceutical industry specializing in the design and implementation of local pharmacovigilance strategies across organizations.
