Description
The Risk Management Product Lead will provide operational support toward the development, implementation, and evaluation of risk management strategies including REMS (Risk Evaluation and Mitigation Strategy) and RMPs (Risk Management Plans). Responsibilities include, but are not limited to:Provide knowledge and expertise related to global risk management regulations, processes, and methodologies to support Risk Management teams
Provide project management support (e.g., project charters, detailed project plans/milestones, progress reports, activity logs and deliverables) for risk minimisation activities, including vendor and financial management
Facilitate implementation of risk minimisation activities for RMPs/REMS
Ensure risk management activities are on track and milestones are met; update the Post Marketing Commitment (PMC) database with this information
Support inspections and audits specific to REMS/RMPs
Ensure standard and consistent global approach to risk management programs across therapeutic areas and business units
Technical skills:
Knowledge of Risk Management regulations and drug development process
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization at various levels.
Demonstrated success in navigating a highly matrix-based organization to deliver against complex program plans
Working effectively when co-located with, AND when remote from, product teams/leaders/managers
Can handle more than one complex project simultaneously
KEYWORDS: Pharmacovigilance, drug safety, risk management