Managing Impacts of Technology Transformations in Pharmacovigilance
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Pharma Tech Outlook: Pharma Tech Magazine

Managing Impacts of Technology Transformations in Pharmacovigilance

Olga Minkov, Executive Director, Operations - Pharmacovigilance & Epi. At Gilead Sciences

Olga Minkov, Executive Director, Operations - Pharmacovigilance & Epi. At Gilead Sciences

Technology advancements in automation and AI for R&D are transforming how we approach work in the pharmacovigilance (PV) space. Nearly every PV conference now features big data and how to leverage analytics to gain new insights from available data sources. Many pharmaceutical R&D divisions are making substantial investments to build data science departments in the hope of answering questions that will aid drug development, including those that help inform on drug safety benefit and risk.

With this technology focus, companies are creating new roles that require understanding of both technology innovation and classic drug development. This type of candidate is challenging to find, and we are seeing a different talent gap emerging in PV as a result. Whereas the focus on building new technical skills has appeared over the last three years, pharmaceutical companies have been focusing on outsourcing a significant amount of R&D work in the last decade. Most pharma today leverages either BPO or CRO partners to complete their Individual Case Safety Reports (ICSR) processing work. As pharma further looks for efficiencies in meeting global regulatory compliance requirements, ICSR case processing continues to be the most common target for automation and AI because of the volume of manual steps involved in this work. With this transformation over the last 10 years, companies are finding traditional PV talent very difficult to find.

Historically, operational PV careers developed while on the job. Most U.S. universities do not have PV majors nor offer drug safety science degrees. European schools have expanded this education in recent years, but most seasoned professionals in PV still learned this work while in the role. Typically, PV candidates came into their role with a health science degree, such as nursing, and learned how to process and report cases in a universal format acceptable to most global regulators. Over time, these employees progressed to leadership positions, learning nuances of various regulations and country-specific requirements for numerous case types and scenarios. Exposure to different drug classes and therapeutic areas further built experience and expertise in the PV space. However, with outsourcing and automation, companies have disrupted the natural evolution of an operations PV career path. Discussions with numerous PV leaders across pharma have confirmed that are all struggling to find experienced PV candidates and are competing for the same diminished talent pool.

To overcome this growing PV talent gap, companies need to reinvest in building the traditional PV skill set. In addition to understanding the key motivators for multi-generational staff, companies also need to focus on mapping out new career paths for their PV workforce. At Gilead we’ve invested in creating PV operations internship roles in an effort to educate life science majors about our function with the aim of joining our PV group upon graduation. Over the last three years we’ve also mapped both hierarchical and horizontal career paths within the group to help identify key skills sets needed for each role. Managers leverage these career maps in development discussions and collaborate across the various operations groups to resource projects or rotate staff to ensure exposure to new skills and PV requirements. Active succession planning discussions are further leveraged to ensure key roles are covered and training for needed skills gaps is addressed.

Although Gilead’s approach is only an example of how one can manage the emerging talent gap, active planning of the PV talent pipeline will be key as technology capabilities continue to transform work in PV. Leveraging these technologies successfully will depend on the preparedness of the team and the agility of the organization to transform their processes to best suit broader global applicable PV regulations.

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