As part of the Global Patient Safety (GPS) leadership team, this role is to ensure end-to-end execution, quality and continuous improvement of global safety operations activities; oversee effective collection, processing, assessment and reporting of ICSRsagainst global standards; oversee safety operations activities in clinical trials, as well as China PV activities, oversee safety systems and reporting activities and actively influence GPS’ operational technology strategyand provide broad and deep technical knowledge.
This role supports and contributes to internal GPS department development and liaises cross-functionally to execute on PV responsibilities.
Essential Functions of the job:
ICSR Activities Oversight
- Oversee development & systematic improvement of safety data collection methods
- Ensure that management, flow, & distribution of safety data is globally consistent
- Oversee data convention standards within the database
- Ensure ICSR submissions to all destinations in compliance with regulation and PV agreements
Trial Safety Operations
- Ensure appropriate representation of SAE data for inclusion in safety-related reports in clinical trials
- Ensure compliance of safety operations activities in clinical trials
- Ensure 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
Supervise China PV responsible person for MAH and DRE, ensuring that the operation and continuous improvement of the pharmacovigilance system to meet the requirements of relevant laws and regulations in China. The main responsibilities of this person are applicable to China include:
- 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 ofPV 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 departments vision and long-range plan
- Participate in 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
Supervisory Responsibilities:
- As Function head, leads GPS Safety Operations Team: Global ICSR Management, Global ICSR Submission, Trial Safety Operations, China Post Marketing Safety Operations, Safety Systems and Supporting
Computer Skills:
- Proficiency with Microsoft office
- Proficiency in technical safety systems including ARGUS and data convention
Education Required:
- MD, PharmD., RN plus higher degree or international equivalent, or the equivalent combination of relevant education or professional experience
Other 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
Travel: International and domestic, up to 20%
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
Salary Range: $285,800.00 - $365,800.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
