Pharmacovigilance Responsible Person- Peru

Bristol-Myers Squibb; Lima Metropolitana; Presencial; PEN 134,000 - 202,000; Jornada completa

Descripción de la vacante

A leading global pharmaceutical company is seeking a Pharmacovigilance Responsible Person in Peru. This role involves acting as the primary point of contact with the Peru Health Authority, conducting local pharmacovigilance activities in compliance with regulations. Candidates should have a relevant university degree, fluency in English, and 2-3 years of experience in the pharma industry. The position requires attention to detail and strong communication skills, offering a chance to make meaningful contributions to health and patient safety.

Servicios

Competitive benefits

Opportunities for career growth

Work-life balance programs

Formación

• 2-3 years' experience in the pharmaceutical industry or medical environment.
• Fluency in English (spoken and written) is essential.
• Understanding of local pharmacovigilance legislation.

Responsabilidades

• Manage risk management plans and safety information.
• Implement PV Audit and Inspection Readiness.
• Report to Health Authorities and maintain data quality.

Conocimientos

Organizational skills

Facilitation skills

Interpersonal skills

Verbal communication

Written communication

Attention to detail

Problem-solving

Educación

University degree in life sciences or nursing

Descripción del empleo

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.

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.

Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén calificadas para la misma recibirán consideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, nacionalidad, edad, discapacidad, condición de veterano protegido, embarazo, ciudadanía, estado civil, expresión de género, información genética, afiliación política o cualquier otra característica protegida por la ley. We are looking for a Pharmacovigilance Responsible Person in Peru. This person will act as primary point of contact with the Peru Health Authority performing all local PV activities required by Peru regulation and GvP. Health care professional (University degree preferably Pharmacist or Biochemistry) 2-3 years’ experience of working in the pharmaceutical industry or a medical environment. Fluency in English (spoken and written) is an essential requisite

Position Summary

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).

Duties/Responsibilities

• 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.

Qualifications

• 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 data bases) 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.

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. 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.

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 [e-mail]. 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: https://careers.bms.com/california-residents/

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