転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です
Drug Safety － Pharmacovigilance Sr. Specialist
年収：900万 ～ 1200万
採用企業案件
オルガノン株式会社
-
- 資本金100百万円
- 会社規模非公開
- 医薬品メーカー
- 医薬品卸
| 部署・役職名 | Drug Safety － Pharmacovigilance Sr. Specialist |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
<会社概要> 当社は、人々が最高の人生を送れるよう、独創的な健康ソリューションを提供している、65億ドル規模のグローバルヘルスケア企業です。主に女性とその家族、そして地域社会に大きな変化をもたらすことに注力しています。私たちの事業は、ウィメンズヘルスにおけるアンメットニーズへの投資、主要なバイオシミラー医薬品へのアクセスの拡大、多様で信頼できるヘルスソリューションによる生活への貢献であり、事業規模は現在もますます拡大しています。 当社のビジョン：すべての女性に、より豊かで、より健康的な毎日を。 私たちは、そんな当社を支えてくれる、情熱的なチームプレーヤー、好奇心旺盛なイノベーター、前向きで、キャリア形成に積極的な、変化と進歩を柔軟に受け入れられる人材を求めています。 当社では、新興企業ならではのオープンで機敏、かつ協力的な社風と、世界140を超える市場にサービスを提供する、フォーチュン500にも名を連ねるグローバル企業という、両方の長所を享受することができます。 エキサイティングな未来のために、当社で一緒に働きませんか！ Position overview: The Pharmacovigilance Senior Specialist will be a part of Regional Regulatory Affairs and affiliate Pharmacovigilance organization and reporting into the head of Japan Pharmacovigilance. The PV Sr. Specialist is responsible for all PV activities and may serve as the PV contact with local stakeholders, headquarters (HQ) and the local health authority, collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting schedules such that there is no gap in adverse event reporting and safety oversight. The PV Sr. Specialist is also responsible for PV activities (as delegated/assigned by their Manager) which may include but are not limited to: management and negotiation of local PV agreements, local due diligence activities, participation in audits and inspections and related readiness activities, local initiatives, SOP management, local training, communication of safety issues, people development, and/or special projects and can work on these delegated activities with minimal supervision. The PV Sr. Specialist may serve as the deputy/back-up Qualified Person for PV (QPPV) / Local Responsible PV person as required per local PV legislation. In the absence of their Manager, he/she is responsible for managing all day-to-day activities of the PV and RA department and serves as their back-up. Primary Activities 1. Serves as the back-up PV Responsible person/ Safety Management Supervisor as required per local PV legislation. 2. Oversees all daily PV processes and activities within the countries covered by the country operation as required. 3. Responsible for execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation 4. Performs reconciliation activities for PV cases received from local operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners (as applicable) and processes the reports in accordance to local procedures/ PV legislations 5. Provides support for Patient Support Programs (PSP) and/or Market Research vendor(s) related activities, as applicable 6. Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements. 7. Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues. 8. Serves as SME and supports local PV audits and inspections including readiness activities and supports other audits/inspections including the development of CAPAs in response to findings/observations. 9. Participates in and supports audits of contractual partners/vendors as necessary. 10. May be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements. 11. Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality PV data and evaluates processes for potential improvement in efficiency and effectiveness. 12. Develops and maintains local PV controlled documents (i.e., SOPs, training materials) ensuring that they are kept current 13. Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders. 14. Leads the training of PV staff and supports the required training of the local company staff, distributors, vendors, business partners including training documentation. 15. May be assigned responsible for ensuring PV language is included in local agreements, liaising with business partner as required, and ensuring maintenance of the database related business partner with respect to local and regional contracts. 16. May be assigned responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures and ARMMs locally 17. Serve as the point of contact for the local Health Authority for PV related questions from the Health Authorities (when assigned) 18. Liaises with the local business units to keep them apprised of safety activities and provide input on strategic decisions (i.e., new clinical trials, product launches, etc.) with Management oversight 19. Participate on local company committees and councils (as appropriate) for matters impacting PV |
| 労働条件 |
Full-time Regular employee Hybrid working style |
| 応募資格 |
【必須（MUST）】 Essential Requirements：・Over 15 years of experience in pharmacovigilance work ・Undergraduate degree or above (life science department) ・Japanese : Native level, English: Business Level ・Management experience of group leader level ・Willingness, positivity, and flexibility to take on new things and new tasks. ・Attitude that emphasizes compliance, responsibility, courage, and integrity ・Negotiation skills ・Leadership 【歓迎（WANT）】 Desirable conditions and qualities：・Knowledge of medical Device ・Knowledge of handling safety information of investigational drugs |
| アピールポイント | マネジメント業務なし フレックスタイム |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/04/09 |
| 求人番号 | 3437275 |
採用企業情報
- オルガノン株式会社
-
- 資本金100百万円
- 会社規模非公開
- 医薬品メーカー
- 医薬品卸
-
会社概要
【設立年月日】2020年3月31日
【代表者】櫻井 亮太
【資本金】1億円
【本社所在地】東京都港区南青山1-24-3
【事業内容】医療用医薬品輸入製造販売
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です