Sr. Mgr of Global Risk Management (AdvancedGroup_415051) Berkeley Heights, New Jersey
Job Number: 415051
Sr. Mgr of Global Risk Management
Risk Management Plan Development Maintenance
• Update risk management plans (e.g. REMS, EU RMPs) of all company marketed products.
• Initiate risk management plans updates as described in Work Practice (WP).
• Disseminate risk management standards to departments and partners
• Oversee the maintenance and update of an RM electronic repository with Risk Management designee Europe
• Prepare and update RMP documents as directed for regulatory submission
• Assist in the delivery of RM standards documents e.g. abstracts
Global RMP Governance
• Assist with the coordination of development of appropriate RM processes (e.g. SOPs, WP’s)
• Assist RM lead on the update of EU RMPs
• Participate as the RM Standards representative on Regional Risk Management Teams (RRMT), Development Risk management Team and Local RM Operation teams.
• Review RM relevant sections of documents e.g. Prescribing Information, Clinical Trial Protocols.
• Ensure relevant RM Standards are internally communicated, including to the EU Qualified Person in a timely fashion.
• Support the development of local RMPs worldwide as directed by the Executive Director, Global Risk Management or Director Global Risk Management
• Participate in drafting responses to inquiries pertaining to the RMP.
• Develop and maintain a tracking system for RM-related inquiries with designee of Risk Management Europe.
• Support Corporate Compliance during RM audits
• Support the development of tools to measure the effectiveness of RMP, and make recommendations as appropriate.
• Maintain close liaison with relevant departments
• Establish supportive relationships with affiliates and business partners in their development of local and regional RMPs.
• BA/BS in health-related discipline, MS preferred.
• 5 years of industry experience either in a clinical or safety-related role
• 3+ years in risk management and/or writing Europe Risk
Management Plans or other equivalent regulatory documents
• Previous experience working within a comprehensive risk
management program is desirable.
• Must be process improvement leader in cross-functional capacity and systems development experience is required
• Extensive knowledge of clinical trials and drug development
• Knowledge of commercial drug environment for risk management products
• Understand safety data