Global Safety Senior Manager

Payrate: $55.00 - $60.00/hr.

The Global PV Sr. Scientist works with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations. This person will also provide scientific and compliance expertise as needed to GPS.

• Directs the planning, preparation, writing and review of portions of aggregate reports
• Organize and direct liaison for activities with affiliates and other internal partners regarding products
• Supports and provides oversight to staff with regards to safety in clinical trials to:
  • Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
  • Review of AEs/SAEs from clinical trials as needed
  • Review standard design of tables, figures, and listings for safety data from clinical studies
  • Participate in development of safety‑related data collection forms for clinical studies
  • Participate in study team meetings as requested or needed
  • Signal detection, evaluation, and management—perform data analysis to evaluate safety signals and write up analysis results
  • Document work as required in the safety information management system
  • Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
  • Search and review adverse event data, literature, and other safety‑relevant data for the purpose of signal detection
  • Prepare presentation of the Global Safety Team’s recommendations on safety issues to the cross‑functional decision‑making body
• Assist GSO in the development of risk management strategy and activities to:
  • Provide contents for risk management plans
  • Develop or update strategy and content for regional risk management plans
  • Assist GSOs to oversee risk minimization activities including tracking of activities as needed
  • Evaluate risk minimization activity
  • Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
• Support activities related to new drug applications and other regulatory filings to:
  • Assist GSO in developing a strategy for safety‑related regulatory activities
  • Provide safety contents for filings

• Organization, prioritization, planning skills
• Collaboration with cross‑functional team settings
• Meeting management and time management skill
• Process and project management
• Critical scientific assessment and problem solving
• Strong written and verbal communication skills, including medical/scientific writing
• Computer skills (e.g., MS Office Suite and safety systems)
• Strategic thinking
• Influencing and negotiation in a cross‑functional, matrix environment
• Presentation skills for conveying complex technical content to non‑expert audiences

• Doctorate with 2 years, Master’s with 6 years, Bachelor’s with 8 years, Associate’s with 10 years, or High School/GED with 12 years of directly related experience. A BS/BA in Life Sciences with an MS and 6 years of experience is also acceptable.
• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Clinical/medical research experience
• 6 years of experience in a biotech/pharmaceutical setting
• Previous management and/or mentoring experience

• Direct Pharmacovigilance experience (Not PV operation or safety reporting)
• Safety signal assessment and management experience
• Aggregate data review and assessment

The typical base pay for this role across the U.S. is: $55.00 - $60.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full‑time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.