Senior Manager, International Patient Safety - Poland Hub

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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 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 team. In 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 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.

Compensation Overview: Warsaw - PL: zł227,340 - zł275,484

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 employee’s 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.

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.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

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R1599984 : Senior Manager, International Patient Safety - Poland Hub