Risk Management Associate Director
Job Post Index
229DE2-Sy##
Location
Cambridge, MA
Description:
Description
- 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
Skills:
Qualifications
- 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.)