Provides subject matter expertise in Risk Management Plans (RMPs) (including, EU RMPs, core RMPs and local RMPs) across therapeutic areas.
Provides subject matter expertise in risk evaluation and mitigation strategies (REMS), across therapeutic areas within GPSE.
Advise on the strategy, preparation and authoring of RMPs and REMs for products across therapeutic areas (including, risk minimization measures, other RMP commitments and responses to health authorities requests).
Maintain collaborative working environment with RMP/REMS vendors.
Maintain collaborative working with GPSE sub-functions, local offices and functions outside of GPSE.
Ensures product team compliance with GPSE risk management processes, as well as current RMP/REMS regulatory trends/guidelines and best practices
Advise product teams on the maintenance and authorship of EU RMPs, core RMPs and other RMPs (e.g. local RMPs) including those for first or supplementary MAA and NDA submissions
Collaborative working with RMP/REMS vendors
Support administrative activities associated with the oversight and management of vendors
Tracking of RMPs and RMP commitments
Ensure regionally aligned principles and standard practices for risk management are consistent with global risk management policy and global benefit-risk assessment
Support RMP/REMS process improvement
Promotes a culture of risk management and benefit-risk excellence
Collaborate with GPSE sub-functions and with partner vendors to deliver RMP / REMS deliverables
Administrative activities - invoices, contracts, etc. - in collaboration with product teams
Advanced degree in life sciences (preferred)
Minimum of 7 years of pharmaceutical/device industry experience with at least 3 years in pharmacovigilance and risk management
Experience with developing and authoring RMPs and REMs, risk minimization tools
Experience with developing and authoring other Pharmacovigilance safety reports (e.g. PSURs/PBRERs)
Experience with the implementation of RMP additional risk minimization measures or activities
Experience with assessing the effectiveness of additional risk minimization measures or activities, and the evaluation of REMS methods
Experience of oversight/management of vendors
Strong track record of scientific and analytical thinking
Integrity and leadership
Experience with writing in past roles helpful
Ability to relate well to people and to motivate and empower others
Capacity to take initiative and work productively in a high pressure environment
Clear communication skills
Project management abilities and insights required to work productively in a global company and across multiple functions
Strong knowledge of business area and understand the proactive interactions necessary to achieve business goals and objectives
Capacity to manage time and priority constraints as well as manage multiple priorities simultaneously
Attention to detail
Computer literacy, including knowledge of safety database
Ability to lead meetings and teleconferences, both internally and externally to technical and lay groups and public meetings
Good understanding of PV and PV documents
Global safety lead/PV safety lead role experience helpful
Willing to accept less than 7 years risk management experience but good amount of PV needed
Knowledge of regulations
Soft skills: prioritization, patience, proactive to find answers (doesn't need to have all answers but needs to find them through collaboration, etc.)