Senior Drug Safety Associate （シニア安全性アソシエート）
募集要項
| 年収 | 800万～1000万 |
|---|---|
| 雇用形態 | 正社員 |
| 職種 | 前臨床研究(薬物動態) |
| 仕事内容 | Assist with the overall Clinical Safety and/or Pharmacovigilance ＆ Drug Safety operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting （i.e., unsolicited reports） Manage and process expeditable adverse events to the required standard and submit them to the client and the regulatory agencies （if required） within the agreed/stated timelines. The post holder is responsible for providing this service to clients either as a support function to the client project groups or as stand－alone business. It is the responsibility of the post holder to provide all clients, both internal and external. With the appropriate quality of service in a safe and cost－effective manner. The Drug Safety Associate will be expected to comply with the legal requirements of the Health ＆ Safety at Work Act 1974, the COSHH regulations 1989 and any local requirements as documented in the Company’ |
| 求める人材 | 【求める条件】 BS/BA ＋ 3－4 yrs safety experience ＊Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions 【歓迎条件】 Good verbal, written and presentation skills Good communication Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level High degree of accuracy with attention to detail Functions as a team player Ability to present and share useful business information across departments and functions Ability to anticipate and identify problems and take appropriate action to correct Knowledge of medical and drug terminology Knowledge of Good Clinical Practice （GCP） related to clinical safety documentation Knowledge of ICH Guidelines Knowledge of Medical Device reporting desirable Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investig |
会社情報
| 会社名 | 会社名は非公開です |
|---|---|
| 業種 | 医療用機器・医療関連 |
| 資本金 | 1000万円 |
| 従業員数 | - |
