Manager, ICSR In-line Quality Review
6 months ago
Description
The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.Position Summary
This global role with focus area of ICSR in-line quality, 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. This role will provide support to the (line manager) to ensure consistency of approach with respect to case processing that is compliant with regulatory requirements and company standards. This role will also collaborate with WWPS functions and act as a liaison with external functions involved in quality of ICSRs to maintain high standards of ICSR quality and contribute to the safety assessment of our products.Position Responsibilities
Conduct in-line quality review of ICSR's to ensure accuracy, completeness, and compliance with regulatory requirements and company conventions. Identify and escalate any discrepancies and quality issues observed during the review process. Provide guidance and support to the case processing team on quality related matters. Collaborate with cross functional teams, including PV Compliance & Quality, Medical Safety Review, Case Processing Vendor, to ensure alignment on safety related activities. Develop and maintain quality metrics and reports to track performance and identify areas for improvement. Participate in the development and implementation of training programs for case processing staff. Stay updated on relevant regulations and guidelines related to PV. Contribute to process improvement initiatives to enhance efficiency and effectiveness in case management activities. Drive innovation through identification of opportunities to leverage technology and process optimization where applicable. Participate in internal audits as needed and ensure timely resolution of any findings related to ICSR quality. Exhibit the BMS behaviors and values.Degree Requirements
Bachelor’s degree (B.S./B.A.) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy; advanced degree preferred.Experience Requirements
A minimum of 5-7 years of experience with processing of adverse event in safety or clinical setting, with a focus on ICSR quality, understanding of medical concepts, biology and chemistry in support of relevant data capture, and data elements driving safety reporting requirements.Key Competency Requirements
Thorough understanding of Regulations, GCP, ICH Guidelines as they apply to coding of medical terminology. 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. Excellent attention to detail. Demonstrated ability to analyze and interpret complex problems/data gathered from a variety of sources and, through effective decision-making and planning, deliver superior business solutions. Demonstrated ability to work with a range of technically and culturally diverse people, influencing them to accomplish common goals. Experience of being able to successfully and productively supervise a team of individuals. 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. Ability to work independently and manage multiple priorities in a fast-paced environment. 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/utilizes 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 Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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