Note: The job is a remote job and is open to candidates in USA. BeOne Medicines USA, Inc. is focused on fighting cancer and is seeking an Executive Director of Safety Operations to lead their Global Patient Safety team. This role involves overseeing safety operations activities, ensuring compliance with global standards, and enhancing pharmacovigilance systems within clinical trials and post-marketing in China.
Responsibilities
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Skills
- MD, PharmD., RN plus higher degree or international equivalent, or the equivalent combination of relevant education or professional experience
- 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
- Proficiency with Microsoft office
- Proficiency in technical safety systems including ARGUS and data convention
- Process and systems management experience preferred
- Clinical experience preferred
Benefits
- Non-Commercial roles are eligible to participate in the annual bonus plan
- 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
- 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
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