PP07-54: Global Pharmacovigilance Strategic Management and Oversight: Study of A Partnership Model
Director, Service Operations, Lifecycle Safety
1. To identify a suitable partnership model for outsourced global Pharmacovigilance strategic management and oversight activities
2. To recognize the challenges, advantages, limitations and opportunities of the outsourced partnership model
Role-based and unit based models were conceptualized. Model suitability was identified considering transition, training needs, ramp-up, and oversight aspects. Challenges, advantages, limitations and opportunities were identified during the process of implementation, through feedbacks and learnings.
The role based model was identified as a suitable partnership model for implementation considering the complexity of activities, efforts variability, transition, workflow assignment, operational and governance oversight. Sixteen role-based activities were transitioned within 3 to 6 months (Avg. 4.5 months). The training requirements spanned between 2 to 4 months (Avg. 3 months). The ramp-up for of role-based model was achieved within +/-1.5 months of expected timelines. The governance oversight forums reviewed 32 critical path deliverables, 20 key performance indicators and managed 2 escalations during the first year. The challenges identified were in the areas of contract, resource recruitment, and skill match for the roles. The advantages included cost efficiency, business continuity, and reduce the number of resources for steering and oversight. The limitation identified included high priority product assignments, knowledge of the legacy activities, and lack of clear processes. Within the medical, safety sciences, case management, safety systems and periodic reports analytics, additional roles (4) were identified for implementation in the model. This type of model facilitated the upskill pharmacovigilance talent in emerging markets.
Typically, the strategic management and oversight activities are managed within the pharma companies. The role based global Pharmacovigilance strategic management and oversight activities partnership enables the next wave of compliance driven outsourcing allowing further cost savings for global Pharmacovigilance operations. The partnership model initially includes established products which can be further expanded to high priority products. Several highly skilled niche roles involved in medical, safety sciences, case management, safety systems and periodic reports analytics can be effectively managed using an outsourced role based partnership model. The pharmacovigilance delivery hubs in emerging markets can be utilized for lead oversight roles in global pharmacovigilance activities maintaining compliance and cost efficiencies.