PV Operational Associate

hace 2 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 www.abbvie.com. 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html.

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

https://www.abbvie.com/join-us/reasonable-accommodations.html

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