Global Case Safety Report Processing Manager
1 month ago
Job Summary
This is a global role which supports the Worldwide Patient Safety vision through understanding the impact and implication of daily work deliverables, policies and procedures on all stakeholders of single case safety reporting. This commitment drives dedication to quality and adherence to global single case regulatory reporting requirements.
Key Responsibilities
- Ensure effective reporting of ICSRs to all applicable regulatory authorities, business partners and WWPS customers in accordance with applicable global regulatory requirements and WWPS principles.
- Review the cases for reportability in Submission Listing in the Company Safety Database and complete submission as required.
- Monitoring distribution and submission failures, including oversight of Case Processing team.
- Monitor receipt of ICSRs submission acknowledgments
- Escalate technical issues to the Database vendor and support resolution.
- Provide input on database releases and support UAT.
- Monitoring IND/New Drug Application (NDA) License Approvals and protocol approval in the USA
- Review of annual IND Reports
- Review of SAE Management Plan
- Quality Check of reportability decision for manual submission
- Quality Check of newly implemented distribution rules
- Perform ad hoc Retrospective review of reportability.
- Update the ICSRs Reporting Requirements in the Global Pharmacovigilance Requirements Repository for USA and EMA
- Review and promptly address submission related correspondence in the AEP mailbox.
- Impact analysis for CAPA/deviations – inclusive but not limited to manual distributions and reportability assessment, rules investigations.
- Work effectively with project teams, business partners, vendors and colleagues to ensure solutions are implemented in a timely manner.
- Drive innovation through identification of opportunities to leverage technology and process optimization in collaboration with applicable WWPS sub-functions not limited to BCI and Global Safety Systems in accordance with established QMS.
- Identify capabilities necessary to further enhance the case management organization in alignment with WWPS strategy.
- Represent Case Management in PV audit and Regulatory inspections and contribute to subsequent CAPAs as needed.
- Inspire and motivate peers to pursue excellence and identify methods for innovative process improvement and/or process efficiencies.
- Exhibits the BMS behaviors and values.
Requirements
Bachelor's degree (B.S./B.A.) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy preferred.
A minimum of 5 years' experience (or equivalent) in processing adverse event reports, designing processes to ensure compliance with domestic and international safety reporting requirements and utilizing databases to support pharmacovigilance activities.
Key Competency Requirements
- Knowledge of international ICSR processing and reporting requirements, regulations, guidelines and procedures.
- Mastery of health / life sciences gained through either formal education or on job experiences.
- Demonstrated ability to analyze and interpret complex problems/data gathered from a variety of sources and, through effective decision-making and planning, delivers superior business solutions.
- Demonstrated ability to work with a range of technically and culturally diverse people, influencing them to accomplish common goal.
- Experience of being able to operate in a matrix environment.
- First-hand experience of working directly with customers, technical experts and professional staff.
- Demonstrated ability to effectively communicate to a diverse audience, at multiple levels within the company, through various formats, i.e., presentations, written proposals/reports/correspondence, leading meetings, face to face dialogue.
- Knowledge of BMS development/planning processes and inherent limitations in order to know who and which resources to engage in making decisions and achieving business results.
- Understanding of organizational structure, operating culture, effective work styles, and achieving results in a change environment.
- Technical Proficiency: Experienced in advanced functionalities of operational tools. Integrates/utilises digital automations tools into daily workflows.
- Problem-Solving: Solves complex problems by reviewing data flows and leveraging digital tools and methods.
- Process Management: Ability to optimize existing processes through incremental improvements and digital enhancements to help pre and post process teams.
- Data Analysis: Uses advanced analytical tools and techniques to interpret and visualize data.
- Critical Thinking: Critically evaluates different options based on evidence and context to form reasoned judgments.
- Data Management: Monitors and reviews data with an eye for anomalies and patterns that could impact workflow or output quality.
- Strategic Thinking: Understands the role of basic digital tools in achieving specific operational goals and can articulate simple digital-based strategies.
- Decision-Making: Uses data summaries to support decisions based on clearly defined options and guidelines
- Change Management: Supports digital change initiatives and communicates their immediate benefits.
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