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Senior Manager Case Processing, Intake and Safety Records

Posted on Apr 6, 2021 by BeiGene, Ltd.

New Jersey, NJ
Research
Immediate Start
Annual Salary
Full-Time


BeiGene 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.


The Senior Manager Case Processing, Intake and Safety Records is:


A regional role based either in Beijing/Shanghai, China San Mateo/Emeryville, CA/Fort Lee, NJ USA/Boston, MA
Responsible for the supervision of safety records staff; the oversight and development of effective intake of safety information, reconciliation with internal and external groups reporting ICSRs; management of follow-up and due diligence activities for ICSRs; metrics-based process management


Knowledge:


Strong competencies with data management practices, document & records management; knowledge of medical terminology; experience with MedDRA and WHO Drug
Understanding of applicable adverse event handling and reporting requirements (eg ICH E2A, E2D, GCP, FDA 21CFR312.32., NMPA Announcements, EU GVP, etc)
Management of teams and working groups preferred


Education/Experience:


Minimum bachelor's degree, or associate's degree in combination with relevant experience
At least 6 years of relevant experience within the pharmaceutical industry
At least 5 years of experience in safety/pharmacovigilance
Experience managing direct reports is preferred


Essential Functions of the Job:


Key Activities: Oversight and management of safety records staff in regional hub (ie US or China) and oversight and execution of processes per data entry guidelines, work instructions and SOPs enabling:


Receipt and Intake


Ensure and oversee the receipt of ICSR from all sources including structured sources (clinical trial SAE report forms, PM AE report forms, electronic formats including E2B, XML, EDC, etc) and unstructured sources (emails, telephone calls, mail)
Monitor the adverse events (AE) mailbox, take appropriate action, including notifying appropriate party of received items that go beyond Global Patient Safety's responsibilities
Download of AEs from regulatory portals as required
Ensure process optimization for identification of valid vs non-valid ICSRs
Identification of accurate regulatory reporting start date ( day zero') and performing duplicate searches of ICSRs
Timely and appropriate handling of all received sources of potential adverse event and special safety situation source documents
Notification of special safety situations to triage and/or medical review physician as appropriate
Support daily safety database workflow to ensure ICSRs are processed according to internal timelines


Reconciliation


Ensure process optimization for reconciliation (ie receipt confirmation) of ICSR and special safety situations from various non-clinical trial sources, such as internal feeder groups (eg Medical Information call centers) and external sources (eg specialty pharmacies, CROs, external partners) as required


Due Diligence


Development and execution of effective due diligence query distribution to external reporters
Support completion and monitoring of due diligence attempts


Quality Assurance


Ensure effective ongoing quality assurance through staff supervision


Performance Metrics


Responsible for the definition and generation of metrics addressing internal timeline & work in progress performance
Manage the root cause analysis of issues revealed by review of metrics
Responsible for the definition and generation of metrics addressing work volumes
Responsible for the determination of actions stemming from metrics review


Continuous Improvement


Responsible for identification of ongoing continuous improvement opportunities within Safety Records Coordination activities
Ensure that identified gaps/issues are addressed and corrected
Ensuring inspection readiness and participation and participate in audit and inspections as required


Compliance, Standards and Training


Responsible for the development of standards and processes to support ICSR Intake and Records management
Responsible for the development of compliance targets and their ongoing determination
Responsible for developing and delivering ICSR Intake and Records management training programs


Vendor Oversight


Training, oversight monitoring, performance metrics review of vendor activities where applicable
Review and confirmation of vendor invoices for accuracy


Decision Making Authority


In process management decisions
Day-to day staff management issues
Staff recruitment
Operational policies, SOPs and WPs
Oversight of all decisions made by reports


Outputs


Process metrics
Consistent process practices
Process timelines consistent with regulatory compliance


Key Relationships:


Safety OPS, ICSR Case Management and Aggregate Safety Reports, Clinical OPS, Medical Reviewers, Product Safety Leads, Safety Scientists, Product Quality


Direct Reports: Manager, Associate and Senior Associate Safety Records


Supervisory Responsibilities:


Management of Safety Records team within a hub (US or China)


Computer Skills: Strong database experience required, proficient with Argus safety database and/or other safety platforms required, proficient with MS Office suite, Excel, PowerPoint,


Other Qualifications: Excellent communication skills (verbal and writing); ability to work in a global team environment; ability to network and partner within global organizations; results oriented and strong attention to detail


Travel: N/A




Reference: 1152693876

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