PV Operational Associate

hace 4 semanas

Santiago, Metropolitana, Chile Allergan A tiempo completo

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn , and Tik Tok .

Job Description

This position is accountable for executing the day-to-day operations and compliance activities to maintain high-functioning PV systems across assigned region remit. Reports directly to PV Operational Team Lead OR Regional PV Lead.

Responsibilities :

Metrics and Oversight of the Pharmacovigilance System

  • Supports the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations and internal company timelines/standards.

Quality Management System

  • Develops and maintains local/regional procedures in line with corporate procedures and local requirements.
  • Performs the impact assessment of new/updated corporate policies, process, and procedures.
  • Actively assists with the PV Exception Reporting/CAPA process.
  • Actively assists with the business continuity plan and testing.
  • Develops and maintains the local PSMF in line with AbbVie's PV system master file, when required by local/regional regulations.

ICSR Management

  • Records, processes, and conducts follow up and translates adverse events and other safety information from spontaneous and solicited sources.
  • Performs ICSR expedited reporting according to the local requirements.
  • Ensures local-language medical or scientific literature review.
  • Implements an appropriate local quality control (QC) procedure to ensure quality of information entered and reporting decisions.
  • Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures.

Periodic Safety Reporting

  • Leads the preparation of periodic safety reports (e.g., PSUR), local annexes, local variations, and translation of safety deliverable documents.
  • Ensures submission of periodic safety reports and ensures documentation of evidence.

Audits and Inspection Management

  • Actively assists in managing internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections.
  • Actively assists in the development of CAPA in response to observations and the tracking actions to completion in a timely manner.

Partnership with business partner with possibility for identification and/or handling of safety information

  • Ensures all PV requirements are in place for activities where there is a reasonable possibility for the identification and/or handling of safety information in accordance with AbbVie procedures and local requirements.

PV Training

  • Ensures overall training compliance with corporate procedures and local PV requirements, including the maintenance of the PV Training Matrix and the development of additional PV training materials, as required.

Legislation Intelligence

  • Monitors local (and applicable regional/area) PV-relevant hard intelligence, leading the impact assessment of them.

Safety Monitoring

  • Understands and monitors incoming local safety data and communicates changes or potential concerns to the PSEQ Product Safety Team Lead and the EU QPPV (for products marketed in the EEA), for evaluation.

After Hours Availability & Business Continuity

  • Ensures availability to be at AbbVie's disposal permanently and continuously on a 24-hour basis, if applicable, and that an after-hours process is in place for the reporting of AEs and that a Disaster Recovery Plan/Business Continuity Plan is established to allow for continuation of critical business processes for PV.

Qualifications

  • A minimum of 2 years experience required within the pharmacovigilance or a related field.
  • Effective communicator and able to work effectively in teams and a cross functional environment.
  • Strong commitment to compliance with relevant rules and procedures.
  • Effective planning and organizational skills, and the ability to complete activities with high quality.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit .

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

#J-18808-Ljbffr

  • PV Operational Associate

    hace 5 días

    Santiago, Metropolitana, Chile Allergan A tiempo completo

    Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...

  • Pharmacovigilance Associate Lead

    hace 1 semana

    Santiago, Metropolitana, Chile Allergan A tiempo completo

    About the Role: This Pharmacovigilance Associate Lead position plays a critical role in maintaining high-functioning PV systems across assigned regions. The ideal candidate will have a strong understanding of pharmacovigilance principles and experience working in a similar role.ResponsibilitiesSupport the development and implementation of local procedures in...

  • PV Operational Excellence Manager

    hace 5 días

    Santiago, Metropolitana, Chile Allergan A tiempo completo

    Role OverviewThis role plays a vital part in ensuring the effective operation of our pharmacovigilance systems. Key responsibilities include:Supporting the development and implementation of procedures to ensure compliance with local regulations and company standards.Providing expert advice and guidance to colleagues on pharmacovigilance procedures and best...

  • Orthopedic Care Expansion Associate

    hace 6 días

    Santiago, Metropolitana, Chile Genesis Orthopedics & Sports Medicine A tiempo completo

    Our MissionWe believe in delivering high-quality orthopedic care to everyone, regardless of their ability to pay. To achieve this, we've developed a new approach that combines innovative treatments with compassionate care. As a Growth Operations Associate, you'll play a crucial role in helping us make this vision a reality.ResponsibilitiesOperational...

  • Associate Solution Consultant

    hace 1 semana

    Santiago, Metropolitana, Chile Genesys A tiempo completo

    Associate Solution Consultant page is loadedAssociate Solution ConsultantApply locations Santiago (Flexible) Santiago, Chile time type Full time posted on Posted 5 Days Ago job requisition id JR107211Genesys empowers organizations of all sizes to improve loyalty and business outcomes by creating the best experiences for their customers and employees. Through...

  • Associate Solution Consultant

    hace 2 días

    Santiago, Metropolitana, Chile Genesys A tiempo completo

    Associate Solution Consultant page is loadedAssociate Solution ConsultantApply locations Santiago (Flexible) Santiago, Chile time type Full time posted on Posted 30+ Days Ago job requisition id JR107211Genesys empowers organizations of all sizes to improve loyalty and business outcomes by creating the best experiences for their customers and employees....

  • Associate Solution Consultant

    hace 2 días

    Santiago, Metropolitana, Chile Genesys A tiempo completo

    Associate Solution Consultant page is loaded Associate Solution Consultant Apply locations Santiago (Flexible) Santiago, Chile time type Full time posted on Posted 30+ Days Ago job requisition id JR107211 Genesys empowers organizations of all sizes to improve loyalty and business outcomes by creating the best experiences for their customers and...

  • Growth Operations Associate

    hace 7 días

    Santiago, Metropolitana, Chile Genesis Orthopedics & Sports Medicine A tiempo completo

    About Us Genesis Orthopedics & Sports Medicine is a premier provider of high-quality orthopedic care and sports medicine services. Our mission is to deliver innovative, compassionate, and cutting-edge treatments that help patients recover, perform, and thrive. We are committed to making top-tier orthopedic care accessible to all, challenging the status quo...

  • Solution Expert Associate

    hace 2 días

    Santiago, Metropolitana, Chile Genesys A tiempo completo

    As a Solution Consultant Associate at Genesys, you will be part of a global team that empowers businesses to create exceptional customer experiences. Our cloud-based platform enables companies to deliver personalized interactions at scale, driving loyalty, engagement, and operational improvements.This role is ideal for recent graduates who want to start...

  • Operations and Development Associate

    hace 5 días

    Santiago, Metropolitana, Chile Genesis Orthopedics & Sports Medicine A tiempo completo

    Job DescriptionGenesis Orthopedics & Sports Medicine is seeking a highly motivated and detail-oriented Growth Operations Associate to support our expanding operations and drive growth initiatives across our organization. This position is ideal for a dynamic individual who thrives in a fast-paced environment and is passionate about improving processes,...

  • Community Associate

    hace 3 semanas

    Santiago, Metropolitana, Chile WeWork A tiempo completo

    Company Address: 75 Rockefeller Plaza Floor 10, New York, NY, 10019 About WeWork Whether you're an established enterprise or a growing startup, discover flexible spaces and solutions to move your business forward with WeWork. Welcome to the workplace of tomorrow. Job Description At WeWork, we provide flexible workspace solutions to help businesses...

  • Support Operations Associate

    hace 6 días

    Santiago, Metropolitana, Chile PagerDuty A tiempo completo

    At PagerDuty, we are dedicated to empowering our customers to achieve operational efficiency and agility. As a Technical Support Specialist II, you will be part of a high-performing team that delivers exceptional customer experiences and drives business results.Your primary responsibilities will include:Managing technical support cases from initiation to...

  • Pharmacovigilance System Associate

    hace 5 días

    Santiago, Metropolitana, Chile Allergan A tiempo completo

    Job SummaryThis role is accountable for the day-to-day execution and compliance activities to maintain high-functioning pharmacovigilance systems across assigned regions. The position reports directly to the Pharmacovigilance Operational Team Lead or Regional Pharmacovigilance Lead.Main ResponsibilitiesSupports the provision of metrics to ensure oversight of...

  • Tourism Operations Executive

    hace 3 semanas

    Santiago, Metropolitana, Chile SGF Global A tiempo completo

    We are looking for a proactive Operations Executive You will oversee and ensure the smooth execution of travel operations, working closely with guides and service providers to guarantee a seamless experience for our clients. Key Responsibilities Monitor the daily progress of assigned travel files. Maintain constant communication with guides and...

  • site lead o&m

    hace 2 semanas

    Santiago, Metropolitana, Chile Atlas Renewable Energy A tiempo completo

    What are we looking for? We are looking for a SITE LEAD O&M - QUILAPILUN for an On-site technical position that supervises the Contracted O&M Provider and has knowledge of the site, equipment, and items impacting site performance, operating conditions, and other items to maximize value and reduce risk. What challenges will you face? Participate...

  • Insurance Business Analyst

    hace 6 días

    Santiago, Metropolitana, Chile Nirvana Insurance A tiempo completo

    Why Work with Us:Nirvana Insurance is a pioneering commercial insurance company that's revolutionizing the industry through cutting-edge technology and innovative risk management solutions. We're driven by a mission to provide businesses with peace of mind by delivering fast, accurate, and transparent insurance products.We're looking for talented individuals...

  • Critical Infrastructure Engineering Manager

    hace 6 días

    Santiago, Metropolitana, Chile Amazon A tiempo completo

    BASIC QUALIFICATIONSHigh school or equivalent diploma.5+ years of relevant work experience in a data center or other critical environment.6+ years of experience with Microsoft Excel, Word, Outlook, and other basic administrative tools.3+ years of experience with managing diverse teams.PREFERRED QUALIFICATIONS6+ years of experience with advanced understanding...

  • Project Manager

    hace 7 días

    Santiago, Metropolitana, Chile Global66 A tiempo completo

    Ecolab has an opening for a Project Manager in our Process Excellence Center of Expertise (CoE) team. The individual will execute short to long-term projects through the use of continuous improvement tools and expertise to address critical business needs with the goal of improving business process, reducing cost, and enabling business growth. The Project...

  • Data Center Facility Operations Manager, Amazon

    hace 1 hora

    Santiago, Metropolitana, Chile Amazon A tiempo completo

    About the RoleWe are seeking a highly skilled Data Center Facility Operations Manager to join our team at Amazon. As a key member of our data center operations team, you will be responsible for ensuring the smooth operation of our facilities, maintaining high reliability and performance, and minimizing operating costs.The ideal candidate will have a strong...

  • Healthcare Business Optimizer

    hace 5 días

    Santiago, Metropolitana, Chile Genesis Orthopedics & Sports Medicine A tiempo completo

    About UsGenesis Orthopedics & Sports Medicine is a pioneering healthcare organization dedicated to delivering exceptional orthopedic care and innovative sports medicine services. Our mission is centered around empowering patients to recover, perform, and thrive through compassionate and high-quality treatments. We challenge conventional practices with bold...