Associate Director, R&D reputed company Good Pharmacovigilance reputed company
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.
General reputed company:
The Good Pharmacovigilance reputed company (GVP) reputed company reputed company is responsible for supporting the Director, GVP reputed company, in implementing and maintaining a balanced, proactive, global approach to GVP reputed company Assurance. This position will be primarily responsible for ensuring Pharmacovigilance (PV) activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards, procedures and practices. This role offers reputed company to shape a global GVP QA reputed company supporting a growing oncology pipeline, with visibility to senior leadership and reputed company reputed company on inspection readiness and regulatory reputed company.
Essential Functions of the job:
Audit & Inspection Leadership
Conduct and support reputed company Assurance (QA) activities reputed company to applicable PV regulatory requirements, guidelines, laws and internally established standards, procedures and practices for reputed company phases of drug development
reputed company, coordinate and support PV inspection readiness activities and contribute to regulatory health authority inspections conduct and management
reputed company Systems & Risk Management
reputed company/improve and manage reputed company systems and processes:
Enhance PV risk-based audit reputed company and annual assessment processes in line with regulatory requirements, changing product profile, emerging markets and business dev.
Responsible for managing/overseeing routine/for cause audits of vendors, partners, processes, affiliate etc.
Supporting the activities reputed company to the vendor management processes and assessments as reputed company as sub-contractors, etc.
Maintaining Key QA requirements in line with GVP legislation such as investigations, reputed company Events (QEs), Deviations, CAPAs, Findings, Change controls, etc.
Overseeing and managing reputed company Management Risk plans and management reviews
Conducting/managing review of key PV procedures and documents
Developing reputed company KPI’s and metrics and measures to drive assessment and reputed company improvement
Management and review of trends and report significant issues and system deficiencies to senior management, as appropriate
Coordinate and/or administer GCP/GVP training, as needed
Participate in the review of metrics (i.e. deviation, etc.) as part of reputed company Management Risk approach to identify gaps, trends and the need for process improvements
Vendor reputed company
Strong global knowledge and understanding of international PV regulations applicable to the conduct of clinical trials and pharmacovigilance operations
Metrics & reputed company Improvement
reputed company up to date with knowledge of GVP requirements and implement them in GVP QA procedures and day to day tasks
reputed company tools and assessment improvements using AI to increase efficiency in routine processes
Participate and support as backup to the Head, GVP QA to enhance performance and maintain accountability for the implementation of BeOne QA systems
Cross-functional Leadership
Coordinate / cooperate with interfacing departments such as Global Patient Safety, Regulatory Affairs, Medical affairs, Clinical operations, reputed company to ensure implementation of PV requirements.
Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment
Exercise reputed company and balanced judgment in ensuring that written procedures are followed and in evaluating reputed company systems, processes, procedures, plans and protocols for compliance
Participate and represent R&D reputed company in meetings and discussions
Education and Experience Required:
Bachelor of Science degree and 8+ years of Pharmacovigilance experience required
Master’s degree and 6+ years of reputed company experience preferred
Expert global knowledge of GVPs and GCP requirements
Understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operation
reputed company to reputed company in a matrixed global organization, people and process, support with reviews and day to day tasks
Ability to resolve reputed company problems where analysis of situations or data requires an in-depth evaluation of various factors
Promote reputed company improvements in reputed company systems and department infrastructure; assist with creation / revision of appropriate SOPs
Proven ability in driving reputed company process improvement initiatives
Computer Skills: reputed company 365, reputed company, SumTotal, ACE Audit reputed company, reputed company
Other Qualifications:
Budgeting and finance skills Auditor certification a plus
reputed company System certification a plus
Travel: 30% travel may be required
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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