Senior Specialist, International Patient Safety - Poland Hub

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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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) 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.

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