Senior Safety & Pharmacovigilance Specialist

外資系大手CROでのPV業務です。新規プロジェクト開始のためのメンバー増員募集です。

仕事内容

・Coordinating workflow to ensure delivery of project.
・Escalates issues with project deliverables, finance and quality to Safety Program DeliveryLead/Manager or Line Manager as appropriate in a timely manner
・Has an understanding of financial measures, work orders, performance metrics (including qualityparameters, monthly budget reports, and changes in scope) and project budgets.
・Prepares Safety Management Plan.
・Assists in the preparation and participates in internal project review meetings as required.
・May enter information into PVG quality and tracking systems for receipt and tracking ICSR.
・May process ICSRs according to Standard Operating Procedures (SOPs) and project/programspecific safety plans.
　・Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
　・Enters data into safety database.
・Codes events, medical history, concomitant medications and tests.
　・Compiles complete narrative summaries.
　・Assesses information to be queried and follows up until information is obtained and queriesare satisfactorily resolved.
　・Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
・Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases
・Ensures distribution of all required individual expedited and periodic reports for both clinical and postmarketing projects to the Safety Submissions team if contracted to submit the reports.
・Provides training of Investigators on ICSR reporting
・Participate in audits/inspections as required
・Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for postmarketing programs as appropriate.
・Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug
development process.

応募条件

【必須事項】

・Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of
education and experience that gives the individual the necessary knowledge, skills and abilities to
perform the job.
・Safety Database systems and knowledge of medical terminology required
・In depth understanding of clinical trial process across Phases II-IV and/or post-marketing safety
requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
・Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook),
TeamShare (or other management/shared content/workspace) and internet.
・Ability to work independently and in a team environment
・Strong communication, presentation, interpersonal skills, both written and spoken
・Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects
・Detail oriented with a high degree of accuracy and ability to meet deadlines
・Able to make effective decisions
・Minimal travel may be required (up to 10%)

【歓迎経験】

【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

3ヶ月

勤務地

東京、大阪

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

フレックスタイム制
フルフレックス（コアタイムなし）

勤務開始日

応相談

休日休暇

年間休日数：120
土日祝
年間有給休暇：　10日 ～
法定休暇：年次有給休暇
特別休暇：年末年始休暇
その他休暇：疾病休暇(5日)※入社月により変動

年収・給与

年収　　550万円～750万円　経験により応相談

諸手当

交通費支給（上限月10万円）、出張手当、時間外勤務手当

昇給

年1回

賞与

年俸制

採用人数

若干名

待遇・福利厚生

通勤手当：有
在宅勤務（オフィス勤務、ハイブリット勤務、完全在宅勤務）、継続雇用制度(再雇用)（一部従業員利用可）、確定拠出年金制度、在宅勤務手当（在宅勤務該当者のみ支給）

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有
定年：65歳

選考プロセス

１）書類選考
２）一次面接
３）最終面接