安全性情報管理システム担当 - 製薬企業 

Location: Ōsaka
Contract Type: Permanent
Salary: ¥7000000.00 - ¥11000000.00 (年収)
Specialization: Technology & Digital, Telecommunication,
Sub Specialization: Business Analyst, Data Analysis/Data Scientist, Data Engineer / DBA, Data Strategy,
Contact: Nobuaki Nishijima
Reference: JO-2207-472401
Nobuaki Nishijima

MANDATORY

  • Applicants must have permission to work in Japan

  • Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)

☑外資系企業☑英語力が必要☑フレックス勤務☑ハイブリッド(出社×リモートワーク)☑在宅勤務可

[ポジション]
安全性情報管理システム担当(SQL必須)

[事業内容・会社の特徴]
大手製薬会社

[仕事内容]

  • Responsible for the maintenance and support of a centralized Pharmacovigilance (PV) reporting process for authorities (inbound & outbound via E2B), tracking of E2B acknowledgements for those reporting and CAPA handling in case of incompliant reporting

  • Configuration and maintenance of E2B R2 & R3 Mappings (inbound and outbound) for the electronic exchange of Individual Case Safety Reports (ICSRs) with health authorities, license partners and internal system

  • Responsibility for act as interface with global PV business functions world-wide, internal and external IT service providers and suppliers for E2B R2 & R3 Mapping (inbound and outbound).

  • Maintenance of case distribution matrix including the list of all reporting destinations as well as the reporting rules per product and recipients (PV country heads through affiliate module, external partners, study teams, etc.)

  • Leads and maintains required PV systems changes, incl. preparation and execution of change controls (like IQ,OQ,PQ)

[応募資格]

  • University Degree or above

  • At least 3 years experience in Pharmacovigilance working with Safety systems

  • Profound knowledge of PMDA, CFDA and MFDS regulations and guidelines

  • Enhanced experiences with the maintenance of a globally operated system for Pharmacovigilance.

  • Extensive knowledge of drug safety processes

  • Ability to work in a very structured and accurate way

  • Required - Maintenance of E2B-configuration within a global PV System

  • Excellent oral and written communication skills in English (TOEIC 730 or above) , and fluency in Japanese

  • Chinese as a further language is beneficial

[給与]
700万円〜1100万円
(能力・経験を考慮し当社規定により決定します。)

[就業時間]
9時00分 〜17時30分 (休憩時間:12時30分〜13時30分)
フレックスタイム制度有

[勤務地]
大阪
在宅勤務可

[福利厚生]
社会保険幹部、退職金制度、慶弔贈与金、出産・育児、介護支援制度、会員制福利厚生サービス、他

[休日休暇]
完全週休二日制(土曜、日曜、祝日)、有給休暇、年末年始休暇(12/29~1/4)、慶弔休暇、産前産後・育児休暇、永年勤続休暇、等

※ご興味をおもちいただけましたら、まずはエントリーをお願いいたします。
ご紹介できる場合は、5営業日以内に担当コンサルタントよりご連絡いたします。
詳細はその際に別途明示いたします。

Reference: JO-2207-472401
#LI-REMOTE
Seniority Level: Associate
Job Function: Information Technology、Analyst