Senior Manager, 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 manages and leads a team of professionals in pharmacovigilance and collaborates with IPS Leadership and Heads of Patient Safety in Countries to ensure an effective model is in place to support PV activities within the scope of the IPS Poland Hub addition this role is responsible for leading overseeing or executing various pharmacovigilance (PV) activities in accordance with local regulatory and legal requirements as well as BMS procedures under the direction of the IPS Poland Hub leader.

Duties/Responsibilities:

• Provides leadership and direct line management to IPS team members based in IPS Poland Hub.
• Contributes to the design and implementation of an effective IPS operating model in the IPS Poland Hub to support in-scope PV activities spanning multiple geographies and liaising with Heads of Patient Safety in applicable countries.
• Collaborates and supports cross-functional teams to ensure effective conduct of PV activities.
• Drives the ideation and continuous process improvements with the IPS Poland Hub team to bring incremental business value-add benefits (increase quality efficiency consistency) and fully leverage available technology.
• Drives cultural awareness and ways of working within the IPS Poland Hub team to enable effective ways of working across multiple cultures and geographies.
• Provides feedback to IPS Leadership on the performance and effectiveness of the IPS Poland Hub to ensure its continuous improvement.
• Addresses any issues or challenges with clear action plans on any activity performed within the IPS Poland Hub working closely with IPS Poland Hub leadership.
• Leads IPS Poland Hub team communications and interactions locally for their direct team (e.g. team meetings and connections with other PS teams).

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.

• Leads the planning or contributes 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/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.)

Reporting Relationship: Reports to Associate Director International Patient Safety Poland Hub.

Qualifications / Experience

• Excellent interpersonal verbal and written communication skills with the ability to effectively engage across different geographies and cultures.
  • Experience working across cultures and geographies is therefore highly desirable.
• Digital competencies with experience of using technology to optimize processes and organizational ways of working.
• Solid understanding of pharmaceutical organizations and their structures and pharmacovigilance systems.
• Able to research compile and provide safety information in a clear concise manner.
• Subject matter expertise in PV legislative matters such as global regional and any other relevant legislation/guidance regarding PV (e.g. FDA EMA 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 leads discussions on process improvement opportunities and co-solutioning with Leadership.
• Has a clear understanding of the broader impact and possible implications on processes/the environment and appropriately consults or escalates (via designated channels) clearly articulated safety issues while retaining accountability.
• Previous line management responsibility with demonstrable experience in developing talent.
• At least 5 years experience in the Pharmaceutical Industry with a minimum of 3 years experience working in Pharmacovigilance or in a closely aligned field (e.g. Regulatory Clinical or Medical Information).
• University degree (health or 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.

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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On-site Protocol

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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.

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

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