Specialist, Pharmacovigilance Innovation - United States
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- Our company is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.
- Our purpose as a company is to discover and develop therapies that will change the course of human health.
- We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
- The Specialist, Pharmacovigilance Innovation, is a global role.
- Reporting into the Executive Director, Global Safety Operations, the Specialist, Pharmacovigilance Innovation is a member of the Pharmacovigilance (PV) Innovation group, a sub-function within Global Safety Operations; a division of Global Drug Safety & Risk Management (GDSRM).
- The Specialist, Pharmacovigilance Innovation contributes to the ongoing development, implementation and successful execution of the Chrysalis program and PV2020 Roadmap ; GDSRM’s strategic plan to enhance data driven decision making and adoption of technologies such as cognitive computing and machine learning.
- As a Subject Matter Expert operating within the Pharmacovigilance Innovation group, the Specialist serves as a key contributor in the development and execution of proof of concept projects, use-cases and activities associated with the end-to-end and end-user experience design of the Chrysalis program platform.
- The individual is responsible for providing critical views of progress and outcomes and contributes to communications, training and change management efforts.
- In addition, the individual assists in the development, review, analysis, and reporting of data in support of Program Management.
- The Specialist, Pharmacovigilance Innovation is responsible for promoting a culture of innovation, collaboration and experimentation within the PV Innovation group; supporting cross functional communication outside of GDSRM, and activities related to the delivery of GDSRM’s PV2020 research and publication strategies, including input into the production of evidence-based scientific literature, white papers and position papers used to support the application and adoption of new approaches to pharmacovigilance.
Responsibilities include, but are not limited to, the following:
- Provide leadership and support to Chrysalis program and other initiatives under the responsibility of the PV Innovation group.
- Support program and project team activities required to implement GDSRM PV innovation initiatives.
- Support management and prioritization of process improvement and innovation initiatives
- Act upon developments in PV landscape; identifying and supporting changes to processes
- Mentor and develop direct reports within the PV Innovation team
- Provision of support and liaison to GDSRM sub-functions in the identification of process improvement opportunities
- Provide strategic support to the functioning of the Chrysalis program Joint Development Committee.
- Manage vendor partners as required, to effectively and efficiently execute the Chrysalis program and other PV2020 related initiatives
- Support the creation, development, and validation of User Interface workflows developed as part of PV Innovation projects
- Manage business activities related to usability testing of new PV systems and processes
- Lead teams involved in conceptualization development of future PV tools.
- Lead the development and management of PV innovation processes and integrate across relevant groups within GDSRM
- Partner with Global Safety Operations team members to lead the design of insight-driven innovative strategies
- Define and provide metric reporting and data analysis for PV innovation initiatives including relevant insights to facilitate decision-making process
- Assess and interpret the process impact of new PV tools and processes
- Represent GDSRM as required on panels at public conferences and workshops related to PV Innovation.
- Work with Chrysalis program contributors and work stream team members to generate opportunities
- In partnership with Global Safety Operations responsible individuals, develop and execute change management and change readiness assessments and strategies
- Support Stakeholder analysis and mapping, identifying potential impacts/risks
- Support activities related to design and implementation of organization and job impact analysis
- Plan and support execution of activities related to organizational change management and end user readiness
- Support efforts related to communication and education of the user community on system progress, objectives, and requirements; and develop means to evaluate and ensure organizational readiness
- Support initiatives to develop employees’ understanding and acceptance of impacts on specific job roles, policies, technology impacts and business practices
- Identify and anticipate organizational challenges and/or resistance; support development of risk mitigation plans
- Support efforts to build change leadership knowledge and capabilities across GDSRM
- Support activities to plan, design, and execute end-user training strategies
- Work with PV Innovation group team members to ensure new tools and technologies are appropriately communicated and effectively incorporated into end user training content
- Support evaluation of instructional approaches for system end-user training
- Conduct and support train-the-trainer workshops as appropriate
- Support the review of end-user training materials, job aids and other materials for consistency and relevance in relation to agreed-upon training objectives
- Support efforts for ‘Use case’ development to identify and capitalize on business process opportunities created by Chrysalis program.
- Provide on-going communication of all assigned PV Innovation deliverables.
- Identify and highlight risks, issues, challenges, obstacles and successes
- Share best practices across PV Innovation group to maximize effectiveness.
- Propose future directions using innovative techniques derived from insights and understanding of process functioning.
- Master’s level degree (or Bachelor’s Degree with relevant experience) in medical or life sciences, or a combination of relevant education or professional experience
- Minimum Three (3) years Drug Safety experience
- Minimum Three (3) years pharmaceutical/biotechnology experience
- Our company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
- Our company complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act.
- All applicants must have authorization to work for our company in the U.S.