Xzencis support for Organizational Change Management

Pharma companies are increasingly seeking to widen the scope of their Drug or Patient Safety departments activities beyond the restrictive straitjacket of pure Pharmacovigilance (PV) compliance. This change is being driven both by  pressure from senior management or by operational initiative and is a response to needs for safer clinical trials, objective-driven product safety development, or a more proactive and forward-looking approach to safety management that does not merely respond to adverse events.

While a mandatory necessity, even the best and most compliant PV cannot meet any of these needs on its own. Many traditional PV departments struggle to define their true departmental goals and objectives, and often find themselves relatively isolated in their organizations, and not seen as part of the R&D value chain. At a corporate level, expectations seldom exceed the “no disasters” objective.

Beyond PV: The Challenge

Apart from required step changes in competence and expertise, re-orientating a Drug Safety department usually requires profound changes within the unit and how the department is integrated into the rest of the organization.

A modern PV department meeting total corporate needs should have operations that are deeply integrated into the overall pharmaceutical value chain of product safety development and management. It needs to forge new collaboration interphases not only to neighboring departments in clinical development and marketed product support but also to players in earlier, pre-clinical stages where Patient Safety is traditionally not present, e.g., Non-Clinical-Drug-Safety.

The organisation needs to create competent, cross-functional Safety Management Teams and furnish them with adequate decision authority, which, in turn, must be balanced by tiered Safety Governance structures and effective conflict resolution principles.

None of this is rocket science. All change elements in isolation are relatively straightforward. The challenge lies in the change process’s lengthy, integrated, and multi-dimensional nature.

A roadmap to organizational change

Change management is an end-to-end process that starts with identifying the true corporate objectives for the remodeled safety department, includes establishing  change process timelines and milestones, along with agreed Key Performance Indicators (KPIs).

It is insufficient to cautiously change a few details here and there. New, more advanced departmental objectives require a minimum critical mass of new structures and working principles.

As always, such changes are subject to all the known challenges of organizational change. Most common is a split mindset reflected in a strong desire to improve coupled with an equally strong unwillingness to change the status quo, often expressed as an inability to move beyond ‘tried and tested’ existing processes and principles.

It is also common for panic reactions to set in once the change process identifies issues in the old system. All too often, even well-intentioned and thought-through organizational change programs deteriorate to a never-ending set of expensive fixes and patches of the old system, particularly where management loses patience and faith in change.

Xzencis support

Xzencis can provide practical support to pharma organizations struggling to implement a strategic safety program.

Its consultants can help in developing realistic expectations, meaningful objectives, executable strategies, and solid safeguards against all the known pitfalls of change management.

Xzencis expertise in transitional safety management (TSM) can help organizations to evolve to more effective structures by implementing concise program-specific or product-specific safety strategies, create cross-functional safety working groups. and establish supporting governance and conflict resolution structures.

These changes do not require additional resources or significant investments so much as determination and new thinking about operational principles.

There is no guarantee of success, and the work and effort must come from the client organization – but it is much easier with competent help.

Resources

Click on Xzencis translational safety services for further information.