Manager, International Patient Safety

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Position Summary

The International Patient Safety (IPS) team ensures robust, compliant, and consistent safety and risk management across all territories in which BMS operates, including Distributor and Local Representative (LR) markets.

This role is responsible for executing various pharmacovigilance (PV) activities in accordance with local regulatory and legal requirements, as well as BMS procedures, under the direction of the IPS Leader (or designee).

Duties/Responsibilities

• Oversee, mentor and guide Senior Specialists in IPS, to ensure high-quality safety deliverables across the team.
• Contribute to/Lead the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures.
• Safety mailbox and communications management.
• Support/Lead Aggregate Report related activities.
• Lead the creation/update of PV Awareness and other related Training content.
• Implementation of Pharmacovigilance Agreements.
• Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees.
• Safety Data Quality activities e.g. PV System Master File maintenance, deviations/CAPA management, other quality control and oversight activities.
• Compilation of PV-related documentation for third parties responsible for Distributor/Local Representative Markets.
• Lead the oversight of the performance of Distributor / Local Representative Market third parties, in line with PV Agreement key performance indicators.
• PV activity planning and tracking e.g. signal communications to Health Authorities.
• Collaborate and support cross-functional teams to ensure effective conduct of PV activities.
• PV Audit and Inspection support (including preparation, conduct and follow-up actions.)

The responsibilities listed above are only a summary, and other responsibilities will be determined by the IPS Leader, as required.

Reporting Relationship

Functional and Managerial reporting lines into IPS.

Qualifications / Experience

• Ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team, under minimal supervision.
• Strong interpersonal, verbal and written communication skills, including the ability to communicate effectively across geographies and cultures, both live interactions and virtually.
• Able to research, compile and provide safety information in a clear, concise manner.
• An understanding of local, regional and any other relevant legislation regarding PV (e.g. ICH, CIOMS).
• Demonstrated ability to review safety information with attention to detail and accuracy, while managing multiple tasks & prioritizing work to meet strict deadlines.
• Utilizes effective problem-solving approaches to address PV issues, seeking support from supervisor when necessary. Ability to comply with relevant internal and external processes/guidelines/regulations.

• Operational Skills:

• 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.

• Analytical Skills:

• 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 Skills:

• 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.

2-3 years' experience of working in the pharmaceutical industry or a medical environment. Ideally having provided PV or medical/scientific information service in a health care environment.

University degree (preferably life science) or nursing qualification.

Written and spoken English communication skills are required (equivalent to Cambridge C2 level proficiency)

Minimal travel is required for this position. Trips could include travel to BMS sites and attending professional meetings and seminars.

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If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 a supportive culture, promoting global participation 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 an 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 eeo -accessibility 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.

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