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新着求人 PMS  (PMS-3)
募集職種 外資系製薬企業の Safety Operation Staff
勤務地 東京、大阪
会社概要 非公開
求人要件 【職務内容】
Safety Operation group staff is responsible for collecting, evaluating, and submitting safety information to the relevant parties (e.g., PMDA, * global Patient Safety, licensing partners) in compliance with regulatory authority requirements, internal procedural documents and safety agreements by collaborating with outsourced vendor.
・Deliver training to the members who are responsible for collecting safety information (e.g., sales reps, CRAs, CROs)
・Support creation of safety information exchange/collection process with relevant parties to facilitate comprehensive and speedy safety data exchange/collection (e.g., global interface organization, safety science, licensees/licensors, clinical study team, medical affairs)
・Create and implement case handling process that addresses to the product specific local RMPs.
・Ensure safety information is reported without delay from relevant parties.
・Ensure safety information (Marketed drug: ICSR; Investigational medicinal product: ICSR, research report, measures taken report, annual report) is submitted without delay to the relevant parties (Regulatory authority, License partners, Clinical Operation, Collaboration partners).
・Support obtaining follow-up information from relevant parties.
・Input requirements to safety systems (e.g., TODAY, CW, LogTri)
・Maintain knowledge of the disease areas for AZ marketed products and investigational products to effectively interface business and science needs to case handling
・Ensure compliance targets are continuously met
・Accommodate changes of the regulatory requirements and critical business needs
・Ensure KPI targets of outsourced vendor are continuously met (quality / performance)
・Escalate any actual/potential compliance issue to an appropriate person (e.g. the line manager) and contribute to resolve
Additional Responsibilities (for band Over D)
・Lead the other group staff to standardize and visualize process
・Effectively work as a liaison in a outsourced vendor- client partnership
・Identify any potential risks/opportunities along with possible contingencies to ensure the appropriate PV activity in order to ensure relevant compliance
・Proactively participate in skill-development, coaching, and performance feedback of the other group staff
・Support or lead case handling related issue management
【対象年齢】 Regardless of age
・Bachelor’s Degree in Science or related discipline
(for all bands)
・Relevant Patient Safety experience in pharmaceutical industry
・Cross-functional project team member experience
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