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Senior Specialist, Patient Safety

Senior Specialist, Patient Safety

0048 BMS ChileRegión Metropolitana de Santiago, Chile
Hace 20 horas
Descripción del trabajo

Working with Us

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more : careers.bms.com / working-with-us.

International Patient Safety

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. Is responsible for performing some or all of the required pharmacovigilance (PV) activities listed below in line with local regulatory and relevant legal requirements and BMS procedures, 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 (HA) and Ethics Committees (as required).
  • Maintenance of PV Awareness and Training.
  • Implementation of Pharmacovigilance Agreements.
  • As applicable, collection, follow-up and forwarding of spontaneous, literature, solicited, post- marketing AE cases.
  • Submission of single cases to local HA and Ethics Committees (as required).
  • Local Market Safety Data Quality.

Note : for greater detail of the specific responsibilities and duties refer to the International Patient Safety Core Activities of the Local Market Patient Safety Personnel. The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.

Key Responsibilities

  • Supports local safety surveillance activities, safety issues, risk management activities, product alerts, patient support programs and market research programs throughout the product life cycle.
  • Provides support for audits and inspections (e.g., preparation, coordination, back room, front room and responses) and communicates and ensures inspection readiness by organizing and maintaining availability of documents such as training records and job descriptions.
  • Assists management in evaluating corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement and ensures adequate and timely closure of CAPAs generated from audits.
  • Coordinates audit plans for pharmacovigilance and post-authorization commitment activities that involve service providers, vendors, business partners and internal audits.
  • Maintains inspection readiness by managing a central repository of drug safety documents, including records of signal detection and other pharmacovigilance (PV) activities pertinent to regulatory inspections.
  • Provides relevant safety information to health authorities, internal stakeholders and external parties.
  • Qualification

  • Ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally, within Worldwide Patient Safety and externally.
  • Develops a good understanding of the BMS organization, in particular the Global and Regional Safety groups. Has a good understanding of relevant local departments e.g. Regulatory and Clinical Teams and how these teams interact (or similar experience in another company).
  • Possess excellent interpersonal, verbal, and written communication skills. Able to research, compile and provide safety information in a clear concise manner to the local / regional team and Worldwide Patient Safety HQ as appropriate.
  • An understanding of local, regional and any other relevant legislation with regard to PV (e.g. ICH, CIOMS), as well as BMS corporate and local systems (e.g. Global Safety Database, local databases) and procedures, in order to fulfill regulatory requirements for pharmacovigilance.
  • Maintains an awareness of the safety profile and any emerging pharmacovigilance / patient safety issues with BMS products (marketed or investigational) in the local affiliate and with support able to represent the local Patient Safety function on cross functional teams, providing input on drug safety issues.
  • 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 solve PV issues, seeking support from supervisor when necessary. Ability to comply with relevant internal and external processes / guidelines / regulations.
  • 2-3 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.
  • Minimal travel required in this position. Trips could include travel to BMS sites, Health Authorities and to attend professional meetings and seminars
  • #LI-hybrid

    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.

    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. We describe roles as site-essential, site-by-design, field-based and remote-by-design. The occupancy type 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 travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

    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.

    BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

    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 : careers.bms.com / california-residents /

    Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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    Senior Specialist • Región Metropolitana de Santiago, Chile

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