Business Quality Analyst (Senior)

PVの知識を活かしてIT企業にてBusiness Quality Analyst

仕事内容

Essential Duties ＆ Responsibilities:

・Interact with client users and internal product owners to gather and author business, functional ＆ non-functional requirements improvements for software products
・Running workshops and pilots with clients for product requirement and implementations
・Application configurations and business process mappings for drug safety and pharmacovigilance clientsIssue / bug prioritization ＆ management in ticketing management system ＆#40;JIRA＆#41;
・Formal system validation (OQs, PQs and IQs) and other SDLC documentation activities like authoring Test Strategy, Test Plan, Traceability Matrix, Test Summary Report, etc.

応募条件

【必須事項】

・Bachelor’s degree from a good college like B.Tech., B.IT or similar
・5-8 years of total experience in software industry with at least 3 years in business and functional requirements analysis and authoring experience in pharmacovigilance domain.
・Medium level knowledge of SQL
・Knowledge of Drug Safety (Pharmacovigilance) domain
・Knowledge of a leading Drug Safety System like Argus Safety, ArigG, etc.
・Experience of system validation in Pharmacovigilance or Drug Safety domain
・Understanding of 21 CFR Part 11 guidelines
・Self-driven personality, ability, and interest to guide junior team members
・Demonstrated proficiency in working on multiple projects and deadlines
・Strong problem solving and troubleshooting skills
・Good communication, presentation, and documentation skills

【歓迎経験】

・Knowledge of periodic/aggregate reporting (PBRER, DSUR, PADER etc.) and signalling
・Business process mapping experience with clients
・Experience of working with enterprise software application
・Working knowledge and experience of Oracle Database, Agile/JIRA, Confluence

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

6ヶ月

勤務地

在宅可、東京

転勤の有無

転勤なし

受動喫煙防止措置

屋内禁煙

勤務時間

通常（実質労働時間との連動）
就業時間：00:00 ～ 00:00

勤務開始日

応相談

休日休暇

年間有給休暇：　

年収・給与

年収　　400万円～800万円　経験により応相談

諸手当

昇給

賞与

採用人数

1名　

待遇・福利厚生

各種制度

選考プロセス

１）書類選考
２）一次面接
３）最終面接