仕事内容

• Enters information into PVG quality and tracking systems for receipt and tracking ICSR.
• May assist in the preparation of the Safety Management Plan
• Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
o Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
o Enters data into safety database.
o Codes events, medical history, concomitant medications and tests.
o Compiles complete narrative summaries.
o Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
o Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
o 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 post-marketing projects to the Safety Submissions team if contracted to submit the reports.
• 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 post-marketing 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.

応募資格

What we’re looking for

• 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

• Good 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

• Good communication and interpersonal skills, both written and spoken

• Good 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

• Minimal travel may be required (up to 5%)

給与情報

ご経験に応じご条件は相談させていただきます。

労働時間

＜標準的な勤務時間帯＞
9:00～18:00
時間外労働有無：有

休暇休日

完全週休2日制（休日は土日祝日）
年間有給休暇15日～25日（下限日数は、入社半年経過後の付与日数となります）
年間休日日数120日

■完全週休2日制（土日祝日）
■年末年始休暇
■有給休暇（初年度15日）※入社月により変動
■疾病休暇（5日）
■夏季休暇は仕事の都合に合わせ有給取得

福利厚生・待遇

通勤手当、健康保険、厚生年金保険、雇用保険、労災保険、退職金制度

＜各手当・制度補足＞
通勤手当：上限月10万円となります
社会保険：補足事項なし
退職金制度：確定拠出型年金（年収の6%を企業が負担）

＜定年＞
65歳

＜教育制度・資格補助補足＞
■社内e-learningシステムLearning Centerによる各種研修プログラム
■英教育最大手ピアソンが提供するGlobal Englishの無料受講

PR内容

担当コンサルタント

担当

Tomoko Ishibashi

興味のある求人があれば転職相談からお問い合わせください

【CRO】Safety & PV Specialist ｜ファーマコビジレンス安全情報コーディネーター

仕事内容

応募資格