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BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION
Language Requirement : Fluent English is Required
Preferred Experience : Pharmaceutical/Biotech Industry
Location : Brazil Remote
General Description:
The Senior Specialist, Global ICSR Management independently executes the triage of individual case safety reports (ICSRs) to ensure initial assessment of cases is in line with processes and regulations.
The Senior Specialist, Global ICSR Management independently executes the case processing and quality control of individual case safety reports (ICSRs) to ensure completeness, accuracy, and quality standards are met for submissions to regulatory authorities and other stakeholders.
The Senior Specialist performs SAE reconciliation between the safety and clinical databases.
The Senior Specialist is responsible for performing tasks in adherence to internal and external timelines and meeting quality, compliance and productivity target metrics, support decision making and provide training.
Essential Functions:
ICSR Case Management Activities:
Upon successful completion of the core ICSR case management curriculum and targeted training for Triage and Case processing tasks under a mentor's supervision, team members will independently manage the tasks. After achieving the required baseline quality results, the Senior Specialist will be eligible to handle all the workflows (Triage, Case processing, QC) based on case workload and business need from all sources (e.g. clinical trials, post-market spontaneous and solicited sources, literature, etc.) to ensure completeness, accuracy, and quality standards are met for submissions to regulatory authorities and other stakeholders.
SAE Reconciliation:
Perform SAE reconciliation between safety and clinical databases.
Track SAE reconciliation to ensure completion and adherence to internal and external timelines and resolve or escalate issues with SAE reconciliation.
Quality and Compliance Indicators:
Meet quality/compliance KPI or metrics.
Productivity and Process Excellence:
Meet productivity/volume KPI or metrics.
Demonstrate problem solving capabilities and execute continuous improvement opportunities within ICSR management.
Decision Making:
Make process decisions consistent with operational policies, SOPs and WIs.
Vendor/CRO Management:
Execute ICSR related activities as described in PV Agreements/Contracts following instruction.
Training & Onboarding:
Deliver training to new team members.
Develop and update training materials.
Provide feedback to line manager for review about new team member onboarding status.
Support resolving issues or escalate to line manager for new team members.
Minimum Requirements – Education and Experience:
Minimum bachelor’s degree (major in life sciences, clinical medicine, nursing, pharmacy), or other health care professional or the equivalent combination of relevant education or professional experience.
Advanced degree preferred Global Patient Safety
Other Experience:
Minimum 2 years' experience in drug safety/pharmacovigilance or relevant clinical experience, including training required.
Understanding of Global regulatory requirements (i.e. ICH, GVP, FDA 21CFR312.32, 314.80, GCP, NMPA Announcement (No. 66, 2018), PAL of PRC (Dec 2019)) for capture and submissions of pharmacovigilance individual case safety reports to FDA, CDE/NMPA, EMA, MHRA, and other global regulatory authorities/national competent authorities.
Understanding of databases, case processing activities, including data acquisition/intake, triage, coding, narrative construction and due diligence activities.
Excellent communication skills (verbal and writing).
Strong problem-solving skills.
Effective time management skills.
Results oriented and strong attention to detail.
Supervisory Responsibilities: N/A
Travel: N/A
Computer Skills:
Argus safety database and other platforms required, MS Office suite, Excel, PowerPoint, Visio, digital skills are preferred.
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
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.