Pharma

Excelling in PV is not only about Technical Expertise

by JP Clement, MD

For a PV leader, to be successful can look like a daily Herculean work: meeting a crucial mandate to minimize harm to patients, while ensuring that a product is prescribed to the right population, and maintaining the highest level of compliance within a very complex set of worldwide regulations.

Acquiring and maintaining a solid technical expertise on the PV world is one fundamental step on this road to success. Understanding the subtleties of the regulations and knowing the trends which will design the future of PV is also key. However, in addition to the technical competencies and subject matter expertise, a set of new, non-traditional behavioral competencies must be acquired by PV teams to maximize their strategic and operational output. We can pick four worth considering.

Change Management: to adjust quickly and anticipate the next move, PV teams need to be savvy in organizational transformations and transactional performance. Operational excellence and high strategic output will only occur in organizations where there is a constant drive for challenging the status quo, find opportunities to increase operational efficiencies while maintaining an acute focus on compliance, quality and patient safety. This includes becoming a change agent, able to develop and implement a compelling vision, and recruit champions beyond the PV traditional perimeter.

Project Management: in a constantly changing environment where processes, systems and organizations evolve quickly, the execution of changes will be accelerated through the application of fundamental project management tools and methodology. Having a project management mindset will greatly facilitate the implementation of major transformations projects and will make a big difference in reaching the desired future state.

Build Partnerships and Alliances: as more operational activities and some key core competencies are transferred to external vendors, it is essential to know how to build an efficient and smooth collaborative mode with such partners. A relation of trust and confidence must be built, based on transparent and open communications. Expectations, performance metrics and clear accountability will minimize frustration. Using empathy in problem solving will help overcome the expected challenges and contribute to a successful team spirit. This is applicable to both internal and external partners.

Communication skills: Pharmacovigilance must take the lead on explaining its strategic contribution to the company vision and mission. The ability to draft and execute a multi-tier communication plan will help the recognition of PV as a unique and valuable expertise center. This communication campaign will also be a tremendous opportunity to learn more about others, recognize their own strategic contributions and capture potential synergies. This is another building element for superb team working.

Pharmacovigilance groups will be best equipped to fulfill the mission to protect patients if they recognize the need to foster such new behavioral competencies while maintaining a deep expertise on best PV practices and worldwide PV regulations.


North America Pharma

Pharmacovigilance and Risk Management Strategies

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