Position Title: PV Director/ Associate Director of PV Risk Management
Work Location: Remote, need to work EST hours
Assignment Duration: 6 Months
Work Arrangement: Remote
 
Position Summary:
As an Director/Associate Director of PV Risk Management, being part of the Risk Management and Benefit risk center of excellence, you will be empowered to work cross-functionally with colleagues to establish and manage the processes for Risk Management, benefit risk, RMPs, additional Risk Minimization Measures and REMS programs and Benefit Risk deliverables.
 
Key Responsibilities:

• Provides guidance and subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide
• Provide guidance and subject matter expertise on the structured benefit risk assessment framework and the development of the benefit risk assessment document
• Engages with partner global functions (e.g. Clinical Science, Med Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety
• Provide strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning.
• Support the development of risk management plans (RMPs) in modular format, review RMPs and ensure alignment with Good Pharmacovigilance Practices and other applicable regulations
• Develop and review risk minimization documents such as additional risk minimization measures (aRMMs) and Risk Evaluation and Mitigation Strategy (REMS)
• Provide subject matter expertise and thoughtful contributions to qualitative and quantitative structured benefit risk assessments
• Provide guidance on incorporation of the patient’s perspective into benefit risk activities (e.g. patient preference studies)
• Collaborate with Safety Leads, Clinical Leads, PV scientists and Clinical Research Scientists, and others cross functional teams on benefit risk assessment strategy
• Develop and provide recommendations for appropriate risk management interventions such as direct healthcare professional communications, educational materials, controlled access program
• Provide guidance regarding tracking risk management commitments including utilization of a tracking platform and system improvement assessment
• Monitor and report risk management metrics to ensure compliance
• Provide centralized support, training and leadership for safety and cross-functional members who work on risk management plans and risk minimizations activities.
• Support inspections and audits activities with regards to risk management processes
• Perform other duties as defined in standard operation procedures or requested by supervisor.

 
Qualifications & Experience:

• Associate Director: PhD/PharmD/DO/MD + 4 years; OR Masters + 7 years; OR Bachelors + 10 years
• Minimum 2 years in PV/safety OR clinical development preferred
• Minimum 3 years of pharmaceutical industry/drug development experience
• Pharmaceutical industry experience, with exposure to PV risk management, additional risk minimization measures and/or REMS programs preferred
• Strong track record of scientific and analytical thinking
• Experience presenting to technical and lay groups at public meetings is desirable
• Demonstrate integrity and work productively in a high-pressure environment
• Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
• Project Management abilities
• Ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
• Able to manage both time and priority constraints and to manage multiple priorities simultaneously
• Attention to details, computer literacy, knowledge of safety databases
• Take initiative and autonomous action
• Proven ability to work in an international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 112.00/hr.