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Senior Specialist, Patient Safety

Senior Specialist, Patient Safety

0048 BMS ChileSantiago, Región Metropolitana de Santiago, Chile
Hace 12 días
Descripción del trabajo

Working with Us

Challenging. Meaningful. Life-changing. Bristol Myers Squibb offers work that goes beyond ordinary roles, with opportunities to grow alongside high-achieving teams in an environment that aims to transform lives. We value balance and flexibility and provide benefits, services and programs to support employees at work and in their personal lives. Care : careers.bms.com / working-with-us

International Patient Safety - Role and Scope

International Patient Safety is responsible for robust, compliant, and consistent safety management and risk management within all the territories BMS operates in, ensuring compliance with global and local regulations and requirements. The role includes performing pharmacovigilance activities under the supervision of the LMPS Lead (or designee).

  • Risk management plans
  • Provision of safety information
  • Implementation of PV Audit and Inspection Readiness
  • Planning, processing, and reporting of Aggregate Reports to Health Authorities and Ethics Committees as required
  • Maintenance of PV Awareness and Training
  • Implementation of Pharmacovigilance Agreements
  • Collection, follow-up and forwarding of spontaneous, literature, solicited, post-marketing AE cases as applicable
  • Submission of single cases to local Health Authorities and Ethics Committees as required
  • Local Market Safety Data Quality

Note : For greater detail on responsibilities, refer to the International Patient Safety Core Activities of the Local Market Patient Safety Personnel. The listed responsibilities are a summary and additional duties may be required.

Key Responsibilities

  • Support local safety surveillance activities, safety issues, risk management, product alerts, patient support programs and market research programs throughout the product lifecycle
  • Provide support for audits and inspections (preparation, coordination, back room, front room, responses) and ensure inspection readiness by maintaining documents such as training records and job descriptions
  • Assist management in evaluating corrective and preventive action (CAPA) findings to identify quality-related signals and trends and ensure timely closure of CAPAs
  • Coordinate audit plans for pharmacovigilance and post-authorization commitments involving service providers, vendors, business partners and internal audits
  • Maintain inspection readiness by managing a central repository of drug safety documents, including records of signal detection and PV activities relevant to regulatory inspections
  • Provide relevant safety information to health authorities, internal stakeholders and external parties
  • Qualification

  • Ability to deliver quality work with strong organizational, facilitation and interpersonal skills in a cross-functional team
  • Develops understanding of the BMS organization, Global and Regional Safety groups, and relevant local departments (e.g., Regulatory and Clinical Teams)
  • Excellent interpersonal, verbal, and written communication skills; ability to research, compile and present safety information clearly
  • Understanding of local and regional PV regulations (e.g., ICH, CIOMS) and BMS systems (e.g., Global Safety Database) to fulfill regulatory requirements
  • Aware of the safety profile and emerging PV issues for BMS products, and able to contribute to cross-functional teams
  • Demonstrated ability to review safety information with attention to detail, manage multiple tasks, and meet deadlines
  • Strong problem-solving skills; ability to comply with internal and external processes / guidelines
  • 2-3 years of pharmaceutical or medical environment experience; PV or medical / scientific information experience preferred
  • University degree (life sciences) or nursing qualification
  • Minimal travel required; may travel to BMS sites, Health Authorities, and professional meetings
  • #LI-hybrid

    If a role intrigues you but doesn’t perfectly match your resume, apply anyway. You could be one step away from work that changes your life and career.

    Uniquely Interesting Work, Life-changing Careers

    BMS envisions transforming patients’ lives through science. Every employee plays an integral role, and our culture supports global participation in clinical trials while values (passion, innovation, urgency, accountability, inclusion, integrity) help every colleague reach their potential.

    On-site Protocol

    BMS has an occupancy structure that determines where work is conducted. Roles are site-essential, site-by-design, field-based or remote-by-design. The required occupancy type depends on role responsibilities and business needs.

    Site-essential roles require 100% onsite presence. Site-by-design roles may offer a hybrid model with at least 50% onsite. Field-based and remote-by-design roles require the ability to travel and attend meetings as directed; travel is an essential job function.

    BMS provides reasonable accommodations to applicants with disabilities and supports their recruitment process. If you require accommodations in the application or recruitment process, contact adastaffingsupport@bms.com. Visit careers.bms.com / eeo-accessibility to view the Equal Employment Opportunity statement.

    BMS recommends vaccination and boosters in line with public health guidance. Qualified applicants with arrest and conviction records will be considered in accordance with applicable laws.

    If you reside or work in Los Angeles County, please review additional information at careers.bms.com / california-residents / .

    Data processed in role applications will be handled in accordance with data privacy policies and regulations.

    #J-18808-Ljbffr

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