パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Pharmacovigilance Specialist
応募 求人ID 64538BR ロケーション 香港 仕事内容
Job Description
応募あとで応募 - Ensures compliance with the CLIENT GPV policies for all Global Business Units as well as local PV regulations.
- Local case intake processing and reporting and ensure full compliance with local and global safety regulations as required by local health authority and CLIENT GPV policies.
- Assist Country Safety Lead (CSL) and serves as the local PV contact for the Hong Kong and Macao authorities, handle PV inspections and audit in Hong Kong and Macao under the supervision of CSL.
- Root Cause Analysis (RCA) & Corrective Actions Preventive Actions (CAPAs) implementation and related tracking activities (ICSRs/ PSRs/ HA queries).
- PV training: perform education and training on safety topics within the local organization, including documentation of attendees and topics covered (i.e.: newcomer training, annual PV Awareness refresh training & training of service providers).
- Assist CSL in Safety Data Exchange Agreement (“SDEA”) management: In case of local agreements with pharmaceutical companies (license-in, license-out, co-marketing-co-promotion, divestment etc.), a local SDEA is in place and implemented, aligned with the local regulations and Global SDEA standards and regularly revised.
- Assist CSL to implement Risk management plan (RMP) management
- Assist CSL in Patient Support Program (PSP)/Market Research (MR) Program/Digital Media program
Qualifications
Job Qualification- Education: Bachelor’s degree of Pharmacy, nurse or other medical science.
- Personnel are always courteous, polite, cooperative and supportive
- Strictly performs duties and responsibilities
- Prompt in implementing indications of the CLIENT CSL in terms of response to attitude, operational matters that need corrective actions.
