Executive Director, Safety Operations

Essential Functions Of The Job

• ICSR Activities Oversight
  • Oversight of development & systematic improvement of safety data collection methods
  • Ensuring that management, flow, & distribution of safety data is globally consistent
  • Ensuring data convention standards within the database
  • Ensuring ICSR submissions to all destinations in compliance with regulation and PV agreements
• Trial Safety Operations
  • Appropriate representation of SAE data for inclusion in safety-related reports in clinical trials
  • Ensuring compliance of safety operations activities in clinical trials
  • Effective liaison with internal & external stakeholders to operationalize and optimize process related to safety reporting including such as Trail Master File (TMF) plan and Safety Management Operation plan
• China Post Marketing Safety Operations
  • Ensure compliance of adverse drug reactions monitoring and reporting
  • Oversee the identification, assessment and control of drug safety risks and ensure the effective implementation of risk control measures
  • Be responsible for the management of drug safety information communication and ensure timely and effective communication
  • Ensure smooth communication channels within the internal stakeholders and business partners, as well as the drug regulatory authorities and the drug adverse reaction monitoring authorities
• Safety Systems and Reporting
  • Oversee Safety database, Safety Reporting, and other associated safety gateways and data repositories
  • Support technical activities and documentation for all safety systems working with other technology teams
  • Oversee development and implementation of PV technology strategies and projects
  • Enhance PV technology footprint within GPS in collaboration with cross departments and in alignment with organizational objectives
  • Develop budget and investment strategies for new technology capabilities to support PV
• Internal Global Patient Safety Dept Development and Liaison with Other Functions
  • Create resource requirement projections for safety operations
  • Recruit, retain, develop, and mentor safety operations staff
  • Create, sign off and maintain policies, guidelines, and SOPs from safety operations perspective
  • Contribute to Compliance Forum and Process & Standards Forum
  • Contribute to audits and inspections
  • Support the development & realization of the GPS department’s vision and long-range plan
  • Support the review of pharmacovigilance agreements and oversee PV agreement execution from safety operations perspective
  • Support outsourcing / vendor selection strategies and relationships from safety operations perspective

Qualifications

• Mastery of global safety regulatory requirements
• Fifteen (15) years relevant experience, including training
• Ten (10) years drug safety experience
• Proficiency in safety report processing & operational systems
• Proficiency of signal recognition, statistical techniques & trials methods & outputs
• Previous management experience
• Process and systems management experience preferred
• Clinical experience preferred

Other Qualifications

• Travel: International and domestic, up to 20%

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Company

• Equal Opportunity Employer