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Global Periodic Reports Scientist
Thousand Oaks,, CADescription:
Note:
Job Details:
Key Activities
CONTRIBUTION
Basic Qualifications:
Top 3 Must Have Skill Sets:
PAY RATE : $92/Hr on W2.
"This posting is for Contingent Worker, not an FTE"
Note:
- FULLY REMOTE
- Global Periodic Reports Scientist
- Organization Global Patient Safety & Pediatrics
Job Details:
- Group Purpose Group is accountable for production and submission of periodic aggregate safety reports (PASRs). Accountable for outsourcing of PASRs and periodic reporting processes, schedules, outputs and metrics throughout the product’s life cycle.
- Job Summary This Sr. Manager position contributes to the design and development for the operating policies and procedures for the maintenance and management of the Amgen Safety periodic reporting processes, schedules, outputs and metrics throughout the product’s life cycle. Assesses the effectiveness of the safety periodic reporting processes to determine areas for continuous improvement. Responsible for effective and accurate interpretation of global periodic reporting requirements and partners in the development of processes to reflect global regulatory trends and guidelines representing best in class. Leads negotiations with partner functions across departments (e.g. Development and Clinical, Regulatory, Biostats, Commercial, Business Partners) to achieve the most effective integration of all available skills, tools, and data into the PASR processes to maximize patient safety. Accomplishes PASR preparation through close collaboration with SMEs and external vendors. Responsible for the successful alignment and tracking of periodic report deliverables to ensure global periodic report regulatory requirements are met. Provides centralized mentoring, training, and leadership for Safety and corporate members who work on Periodic Reports. Provides frequent interaction with management on status of the PASR process.
Key Activities
- Partners in the development of standards for the PASR process,
- Contributes to the design and development of PASR SOPs, QRGS, and applications for PASRs including the development and submission timeline, interface to SMEs within Global Patient Safety and non safety functions that support the PASRs, and QC of documents for completeness.
- Contributes to design and development of software to track PASR processes including the scheduling of PASRs and data specifications for the safety database outputs that support PASR generation.
- Assess the effectiveness of the PASR process for continuous improvement
- Responsible for fostering relationships with the external PASR vendor and all SMEs involved in the PASR process, the development and submission timeline, interface to Global Patient Safety, and QC of documents for completeness.
- Responsible for effective and accurate development and maintenance of Global regulatory requirements and standards for PASRs and serves as level 2 BPO for SOPs, QRGs and templates related to periodic reports.
CONTRIBUTION
- Ensures remains in compliance and becomes best in class with regard to periodic / aggregate report processes
- Responsible to ensure company is active in regulations, guidelines and industry standards that affect the processes of the periodic report processes.
- Executes and maintains document standards
- Responsible for successful alignment and tracking of metrics, timelines and performance indicators for PASR objectives
Basic Qualifications:
- Doctorate degree and 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting
- OR
- Master’s degree and 7 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting
- OR
- Bachelor’s degree and 9years of pharmaceutical, biotech or regulatory authority experience in a research and development setting
- OR
- Associate’s degree and 12years of pharmaceutical, biotech or regulatory authority experience in a research and development setting
- OR
- High school diploma / GED and 14 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting
- OR
- 3 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Education & Experience (Preferred) BS, RPH, RN HCP, or Life Science with 8 - 10 years of directly relevant experience (including 6 years of experience in Drug Safety)
Top 3 Must Have Skill Sets:
- Knowledge of Pharmacovigilance
- Periodic report experience and knowledge of regulations
- Strong understanding of compliance and Pharmacovigilance regulations
- Strong team player will be working with people globally in the organization
PAY RATE : $92/Hr on W2.
"This posting is for Contingent Worker, not an FTE"