COVERSTORY
By Karen Schmidt, Faizan Mujeebuddin, Danielle Abatemarco, Kayt Stewart and Linda James
As departments within the life sciences industry mature, organizations face a critical need to define and measure workforce competencies in a meaningful way that builds domain skills in the context of the organization and the drug-development lifecycle.
BeOne’s Global Patient Safety department developed a comprehensive competency model to align department-specific skills with behavioral competencies, creating a foundation for hiring, onboarding and career development. This article outlines the process, lessons learned and practical applications for life sciences learning professionals.
Competency modeling has become a cornerstone of workforce development across industries, including pharmacovigilance (PV). The International Society for Pharmacovigilance (ISOP) introduced a competency framework and pilot certification program, signaling a global trend toward structured skill development in patient safety operations and safety science.
At BeOne, we leveraged this framework of department-specific expertise and added additional enabling expertise to create a patient safety competency model that encompasses our entire Patient Safety workforce. Implementing this model allows us to assess departmental talent needs and ultimately to justify competency and learning needs to support business objectives.
Deep understanding of our essential job roles is needed for defining role success. Using patient safety competencies, we can build role success profiles that define roles that help us meet business needs. Our competency-informed role profiles provide a common understanding which then guides multiple workforce activities:
Targeted development: Aligns training with role-specific needs.
Career pathways: Enables transparent progression and mobility within patient safety functions.
Consistency in hiring: Provides a common language for evaluating candidates.
Our approach began with cataloging competencies using ISOP role descriptions, internal job family descriptions and industry benchmarks. An intensive analysis of existing job tasks associated with roles, guided by existing competency frameworks resulted in a lengthy list of skills and qualities required across the discipline of patient safety. In comparison with prior frameworks, we expanded our analysis beyond core roles in safety science and safety operations to include essential departmental enabling roles.
Considering the breadth of skills, knowledge and experience required overall, we identified broad categories that could encompass all patient safety roles. We recognized competencies of two basic types:
Behavioral competencies (soft skills): Universal skills such as collaboration and problem-solving are important to our department. These competencies are reflected in existing corporate value areas: bold ingenuity, driving excellence and collaborative spirit.
Department-specific competencies: Beyond global behavioral competencies, which serve all roles, we identified specific technical skills and knowledge in six categories essential for patient safety operations.
From this foundation, we defined six patient safety competency areas:
PV Scientific expertise
PV Digital expertise
PV Operational expertise
PV Regulatory expertise
PV Product role expertise
PV Organizational role expertise
The patient safety competencies comprise all the expertise needed within the PV department overall, with different emphasis depending on job family or role. For example, the safety science roles emphasize PV scientific expertise and PV product role expertise highly, while the PV quality management roles depend more heavily on PV regulatory, PV operational and PV organizational role expertise.
To ensure scalability, we introduced six proficiency levels (Figure 1).
These levels allow managers and employees to assess proficiency and set learning and growth targets. The stages of development in PV competencies correspond roughly to responsibilities in PV roles. If a role requires competency that supports others and represents a contribution to a particular task, Level 2 “supporting” would be a target level for that role. For roles requiring independent application of PV competencies, Level 3 would be the target.
Roles could potentially require a high level of PV operational competency, for example, while not requiring PV scientific expertise. Designating target proficiency separately for each of the six PV competencies opens room for individual development while maintaining needed skills in a role.
Using spider plots and role-based matrices, we mapped competencies to patient safety job families. This visual approach clarified expectations and highlighted gaps, informing hiring and development strategies. (Figure 2)
The model, including competency mapping to roles, also supports multiple applications in workforce development:
Onboarding programs: Align training content with required competency proficiency levels.
Self-assessment: Supports individual development plans and career conversations.
Role success profiles: Define target competency levels, behavioral expectations and qualifications.
Assumptions met reality during our competency model development process. Educational credentials do not guarantee patient safety competency, although competencies can be learned.
There was a need for Proficiency Level 0 (“not present”). Some roles do not require certain competencies and learning efforts should be focused on the other, more essential patient safety competencies.
We found that we needed to define role-specific examples. Broad definitions of the competency categories must be contextualized for each function. For example, digital competency varies by role, depending on the tools used to meet specific business needs.
We plan to continue developing a curriculum centered on the competency-based education model and personalized learning, aimed at achieving outcome-focused results. The six patient safety competencies will serve as the guiding framework for this approach, informing every aspect of curriculum design, resource allocation, performance management and career pathway development.
By using the categorization of each competency’s levels of applying, leading and shaping, we can tailor learning experiences to meet the unique needs and aspirations of each learner.
Learners can progress through competency levels at their own pace, starting with the application of skills, advancing to leading within their areas of expertise, and ultimately shaping the field of patient safety through innovative practices. This structure not only allows for personalized learning pathways but also ensures that learners achieve mastery before advancing.
By aligning educational goals with these defined competency levels, we enhance learner engagement, ensure skill retention and foster technical excellence in patient safety. As we continue to refine the program, the PV competencies will remain the cornerstone of our commitment to cultivating a skilled and adaptive workforce.
Competency models have a much broader relevance. We believe they have potential for application to discussions of business needs and workforce skills throughout the life sciences industry.
Karen Schmidt is senior manager, PV applied research and design for BeOne Medicines. Connect through Karen.schmidt@beonemed.com or linkedin.com/in/karenlynneschmidt/.
Faizan Mujeebuddin, associate director, communications, change management and learning, for BeOne Medicines. Connect through Faizan.mujeebuddin@beonemed.com or linkedin.com/in/faizanam/.
Danielle Abatemarco is chief of staff to chief safety officer for BeOne Medicines. Connect through Danielle.abatemarco@beonemed.com.
Kayt Stewart is senior LMS platform specialist for BeOne Medicines. Connect through Kayt.stewart@beonemed.com or linkedin.com/in/kayt-stewart/.
Linda James is a learning architect for BeOne Medicines. Connect through Linda.james@beonemed.com or linkedin.com/in/linda-a-james85/.
