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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.)

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