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- The Sr. Associate PV is responsible f:
- ICSR Case intake local process
- • Manage contacts of external internal customers in matters relating to drug safety, ensuring that a professional, approachable infmative impression is given at all times.
- • Process spontaneous product safety infmation from various sources (e.g, medical infmation, competent authities, literature) accding to relevant processes stards, using the local case tracking system.
- • Process clinical trial, post authization safety study product safety infmation accding to the relevant processes stards.
- • Perfm local literature review, if applicable.
- • Ensure crect use entry of data in the PV case tracking system
- • Ensure timelines are met f each activity to ensure compliance, moniting at an affiliate level.
- Local PV Quality Management System
- • Maintain appropriate logs databases as necessary f optimal functioning oversight of the local PV department
- • Suppt with writing updating of local PV processes stards.
- • Suppt the PV affiliate lead/Drug Safety Officer (DSO) with internal external PV-related crespondence.
- • Execute routine reconciliations of various databases with PV partners.
- • Perfm routine quality checks on the Out of hours availability at the affiliate accding to relevant processes stards.
- • Participate in the development of safety moniting repting plans f local clinical trials.
- • Suppt the implementation of PV Agreements PV contracts with local vends
- • Ensure crect filing (electronically hard copy) archiving of related documents accding to Good Documentation Practices
- • Update maintain local Quality Documents (QDs) as required.
- • Take part in special PV projects as when needed upon assignment by PV affiliate Lead/DSO.
- • May represent the local PV department in inspections audits. Suppt with PV health authity inspections audits.
- • Suppt in moniting local case submission compliance take the necessary crective / preventive actions locally f late repting.
- • Suppt in repting compliance other PV-related infmation as requested by PV Affiliate Mangement Function.
- • Follow the business continuity plan f eg, system failure disasters in relation to PV activities.
- • Participate in the 24/7 availability to enable appropriate hling of potential urgent safety issues by the affiliate.
- • Submit aggregate safety repts in Kea.
- • Assist in developing implementing K-RMP
- People Organization Management
- • Guides juni colleagues / oversees controls local PV activities
- • Perfms local PV training as needed
- • Responsible f the development maintenance of effective collabations with peers internal PV key stakeholders functions as well as relevant other stakeholders::
- • With Health care professionals consumers using Astellas’ products.
- • With PV Affiliate Lead/DSO delegate (line manager), other local interfaces e.g. Clinical Operations, Regulaty Affairs, Medical Affairs, Quality Assurance Marketing, Sales, Ethics Compliance other business functions.
- • With PV Affiliate Management Team Members
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