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PVマネージャー
年収：800万 ～ 1300万
採用企業案件
役員面接
グローバルレギュラトリーパートナーズ合同会社
-
- 会社規模1-30人
- 医薬品メーカー
| 部署・役職名 | PVマネージャー |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Title: Head of Safety Management ( Anseki) - Department: Pharmacovigilance - Working Style: Hybrid - Position: Part-Time Contractor - Area: Toronomon, Tokyo - Company Type: Foreign multi-national - Supervisor: Sokatsu Summary: Head of Safety Management ( Anseki) . This role is responsible for contributing to establishing and maintaining a local PV organization in Japan. Role & Responsibilities: 1. Overall management of safety operations 2. Communication and coordination with sokatsu. 3. Administer safety management activities and provide instructions on activities related to safety management to personnel within the company (including contractors). 4. Confirm whether the safety management work is appropriately and smoothly carried out, prepare and preserve the record. 5. A person in charge may be designated depending on the content of post-marketing safety control duties, if necessary. 6. SOPs development: writing and review. 7. Development of PV operation Documentation: writing and review. 8. Manage outsourcing of safety management activities. 9. Implementation of GVP trainings for Safety Department. 10. Implementation of Management Review from GVP viewpoints on quarterly basis. EXPERIENCE 1. A person who has been engaged in safety assurance or other similar work for at least 3 years 2. Pharmacist-licensed. KNOWLEDGE AND SKILL - Communication, discussion and negotiation skills with local authorities PMDA, MHLW, and international clients. - Advanced Communication skills – cross-departmental communication necessary. - A positive attitude of Flexibility and agreeableness. - High attention to detail. - Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and office management software. - Produce work with a high level of accuracy. - Professionalism and organization skills - Advance English writing skill, Intermediate English Skill, Japanese -Native |
| 労働条件 |
契約期間：期間の定めなし 試用期間：あり（3カ月） 就業時間：9:00～18:00（休憩1時間） 休日 ：土日、祝日 休暇 ：年次有給休暇/年末年始/慶弔 残業 ：あり 給与 ：詳細は面談の時にお伝えします 通勤手当：会社規定に基づき支給（上限月額30,000円） 社会保険：健康保険、厚生年金、労災保険、雇用保険 |
| 応募資格 |
【必須（MUST）】 - Pharmacist【歓迎（WANT）】 3 years or more of experience in regulatory affairs for Pharmaceuticals.- Experience with communication with PMDA or notified body reviewers. - Good communication skills in English （written and oral） - Sufficient PC skills to administer regulatory datasets and their revisions - Excellent team player Preferred - 3 yrs. or more of experiences as one or more of representative of Pharmaceuticals MAH （Sokatsu Hinseki or Anseki） - Experience in managing regulatory projects - Experience in managing other regulatory people - 3 years or more experience in quality control of pharmaceuticals and or pharmacovigilance - Facilitator - Good analytical and problem-solving skill - Self-motivator and self-learner - Minimum English Level: Daily Conversation - Minimum Japanese Level: Native |
| アピールポイント | 管理職・マネージャー 完全土日休み |
| 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 | 2024/03/26 |
| 求人番号 | 3056239 |
採用企業情報
- グローバルレギュラトリーパートナーズ合同会社
-
- 会社規模1-30人
- 医薬品メーカー
-
会社概要
【設立年月日】2016年10月25日
【本社所在地】東京都港区虎ノ門5丁目13-1
【事業内容】
外資系医療機器および医薬品メーカー向け製造販売業務、コンサルティング業務
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