Senior Specialist or Manager, Pharmacovigilance, Oncology

Role Summary

企業概要

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

求人内容

Purpose

This position is accountable for executing the day-to-day operations and compliance activities by leading a team of PV operations to maintain high-functioning PV systems across assigned region remit. Reports directly to Japan PV Operational 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.

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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 report decisions.
• Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures.
• Periodic Safety Reporting
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• Partner with Safety Science and any other relevant functions, leads the preparation of periodic
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• safety reports of assigned TA' products (J-DSUR, J-PSUR, Non-Serious Unexpected ADR Periodic
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• Safety Report and Re-examination dossier).
• • Ensures submission of periodic safety reports and ensures documentation of evidence. Audits and Inspections
• Actively assists in managing internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections. Partnership with business partner with possibility for identification and/or handling of safety information
• Ensuring 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.

Risk Management (if applicable)

• Collaboration with Safety Science is essential for the following tasks. Do refer to the DOP and JPN GL 04, which are defined separately, for more details.
• Develops a deep knowledge of the Risk Management Plans (RMPs) to obtain information on the risk/benefit profile of products, for implementation of EPPV locally.
• Liaises with affiliate safety science and where applicable, during development or revision of the COUNTRY RMP (if applicable) Safety Monitoring
• For EPPV, understands and monitors incoming local safety data and communicate changes or potential concerns to the affiliate safety science, for evaluation. Launch Readiness
• Collaborate with Safety Science and along with Safety Control Manager to ensure the successful launch of new drugs/additional indications in Japan by executing a solid local strategy to ensure local regulatory compliance.

Affiliate Review Process for research

• Review the assigned TA and products Reg-PMOS protocols from a safety perspective.

資格

Requirements

• 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.
• その他の情報
• アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。

About the Company

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

R&D Process Engineering Organization, a part of AbbVie’s Development Sciences organization, is responsible for designing and developing scalable processes to make drug substances and drug products, including synthetics molecules, antibody drug conjugates (ADCs) and genetic medicines, throughout pre-clinical and clinical development stages. Process Engineering also partners with Biologics CMC (Chemistry, Manufacturing, and Controls) Development and Aesthetics R&D functions to provide active engineering support to enable robust process scale-up and manufacturing of biologics drug substances and drug products including toxins and cosmetic active ingredients (CAIs). It drives the development of innovative engineering technologies and creates valuable intellectual property through the composition of matter and chemical/bio-chemical processes resulting in cost-effective commercial manufacturing processes for quality products.