Senior Specialist, International Patient Safety Poland Hub

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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) operational activities in accordance with local regulatory and legal requirements as well as BMS procedures under the direction of the IPS Poland Hub leader for any territory in which the IPS Poland Hub team is responsible.

Duties/Responsibilities:

The responsibilities listed below are only a summary and specific responsibilities will be determined by the IPS Poland Hub Leader based on in-scope work of the IPS Poland Hub team.

• Contribute to 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 Aggregate Report related activities.
• Maintenance 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.
• 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.)

Reporting Relationship: Reports to Senior Manager International Patient Safety Poland Hub.

Qualifications / Experience

• Ability to provide quality work using strong organizational skills in a cross-functional team.
• Strong interpersonal verbal and written communication skills including the ability to communicate effectively across geographies and cultures both live interactions and virtually.
• Digital competencies ideally with some experience of using technology to optimize processes and organizational ways of working.
• 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.
• 1-2 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.)

No travel is required for this position.

If you come across a role that intrigues you but doesnt 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.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

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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.

Supporting People with Disabilities

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.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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