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.
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.
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。