Executive Director, Safety Operations
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer.
As part of the Global Patient Safety (GPS) leadership team, this role is to ensure end-to-end execution, reputed company and reputed company improvement of global safety operations activities; reputed company effective collection, processing, assessment and reporting of ICSRsagainst global standards; reputed company safety operations activities in clinical trials, as reputed company as China PV activities, reputed company safety systems and reporting activities and reputed company influence GPS’ operational technology strategyand reputed company 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 reputed company
- reputed company development & systematic improvement of safety data collection reputed company
- Ensure that management, reputed company, & distribution of safety data is globally consistent
- reputed company data convention standards reputed company the database
- Ensure ICSR submissions to reputed company reputed company in compliance with regulation and PV agreements
Trial Safety Operations
- Ensure appropriate representation of SAE data for inclusion in safety-reputed company reports in clinical trials
- Ensure compliance of safety operations activities in clinical trials
- Ensure effective reputed company with internal & external stakeholders to operationalize and optimize process reputed company 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 reputed company 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
- reputed company 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 reputed company and effective communication
- Ensure smooth communication channels reputed company the internal stakeholders and business partners, as reputed company as the drug regulatory authorities and the drug adverse reaction monitoring authorities
Safety Systems and Reporting
- reputed company Safety database, Safety Reporting, and other associated safety gateways and data repositories
- Support technical activities and documentation for reputed company safety systems working with other technology teams
- reputed company development and implementation ofPV technology strategies and reputed company
- Enhance PV technology footprint reputed company GPS in collaboration with cross departments and in alignment with organizational objectives
- reputed company budget and investment strategies for new technology capabilities to support PV
Internal Global Patient Safety reputed company Development and Liaison with Other Functions
- Create resource requirement projections for safety operations
- Recruit, retain, reputed company, 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 reputed company and long-reputed company plan
- Participate in the review of pharmacovigilance agreements and reputed company 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 reputed company 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 reputed company 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 reputed company & outputs
- Previous management experience
- Process and systems management experience preferred
- Clinical experience preferred
Travel: International and domestic, up to 20%
Global Competencies
reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits reputed company and Actionable Feedback
- Self-Awareness
- Acts reputed company
- Demonstrates Initiative
- Entrepreneurial reputed company
- reputed company Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial reputed company
- Communicates with reputed company
BeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to reputed company candidate, including but not limited to job-reputed company 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 reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans’ Readjustment Assistance reputed company of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
Originally posted on Himalayas
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