Job Details

Details for the Position

• 6-month contract to start with the possibility of extension or conversion depending on performance and business needs
• Rate: $120-190 an hour depending on experience level
• 100% remote

Job Description

• Associate Director of PV Risk Management, within the Risk Management and Benefit-Risk Center of Excellence, you will work cross-functionally with global colleagues to establish and manage processes related to risk management, benefit-risk assessments, Risk Management Plans (RMPs), additional Risk Minimization Measures (aRMMs), REMS programs, and other benefit-risk deliverables.
• Provide guidance and subject matter expertise on risk management and risk minimization strategies within assigned therapeutic areas to ensure global consistency
• Lead and contribute expertise to structured benefit-risk assessment frameworks and development of benefit-risk assessment documents
• Partner with global functions (e.g., Clinical Science, Medical Affairs, Regulatory Affairs, Biostatistics) to align pharmacovigilance risk management strategies and maximize patient safety
• Provide strategic input to cross-functional product teams, including benchmarking and scenario planning for PV risk strategies
• Support the development and review of modular Risk Management Plans (RMPs), ensuring compliance with Good Pharmacovigilance Practices and applicable regulations
• Develop and review risk minimization materials, including additional risk minimization measures (aRMMs) and Risk Evaluation and Mitigation Strategies (REMS)
• Contribute expert insight to qualitative and quantitative benefit-risk assessments
• Guide incorporation of the patient perspective into benefit-risk activities (e.g., patient preference studies)
• Collaborate with Safety Leads, Clinical Leads, PV Scientists, Clinical Research Scientists, and other cross-functional partners on benefit-risk strategy
• Recommend appropriate risk management interventions such as DHPCs, educational materials, and controlled access programs
• Provide guidance on tracking risk management commitments, including use of tracking platforms and system improvement initiatives
• Monitor and report risk management metrics to ensure compliance
• Deliver centralized support, training, and leadership for safety and cross-functional teams involved in risk management and risk minimization activities
• Perform additional duties as outlined in SOPs or as requested by the supervisor

Required Skills

• PhD/PharmD/DO/MD + 4 years, OR Masters + 7 years, OR Bachelors + 10 years of direct experience leading and contributing expertise to structured benefit-risk assessment frameworks and development of benefit-risk assessment documents
• Experience with PV risk management, aRMMs, and/or REMS programs
• Experience presenting to technical and external audiences at public meetings preferred
• Project management experienceAbility to proactively identify and manage cross-functional interactions needed to achieve business goals