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Safety ＆ Pharmacovigilance Manager
年収：800万 ～ 1000万
採用企業案件
サイネオス・ヘルス・ジャパン株式会社 クリニカル事業部
-
- 会社規模非公開
- CRO
- その他
| 部署・役職名 | Safety ＆ Pharmacovigilance Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
--JOB SUMMARY-- Manages Safety team members responsible for all Safety services while adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines, Good Pharmacovigilance Practices (GVP) and study procedures. Participates in process development, budget reviews, and project management. Ensures consistency and communication between the Safety team members and management. --JOB RESPONSIBILITIES-- > Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counseling. Advises staff on administrative policies and procedures, technical problems, and prioritization. > Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives. > Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with senior safety management. > Manages projects where Safety and Pharmacovigilance are the primary services. ・ Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed. ・ Works with Finance to ensure appropriate customer invoicing, where required. ・ Approves project time cards and invoicing. ・ Provides sponsors with scheduled project updates and reports. ・ Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues. > Participates in the management of the Safety and Pharmacovigilance department with the following actions: ・ Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) ・ Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan. ・ Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions. ・ Works with Business Development to actively solicit new business, as needed. ・ Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings. > Reviews, advises, and approves Safety portions of project proposals to ensure wording adequately reflects the scope of work for Safety and Pharmacovigilance. Participates in bid defense meetings. Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure information is consistent with the Serious Adverse Event form. Approves budget pro jections for the project. > Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug development process. > Responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups. Mentor Safety team members > Managing resourcing's needs/issues and escalating to senior management as necessary. > Participates in audits/inspections and ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventive actions. > Performs other work related duties as assigned. > Minimal travel may be required. |
| 応募資格 |
【必須（MUST）】 --QUALIFICATION REQUIREMENTS--・ BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience ・ Progressive responsibility with demonstrated leadership skills and project management ・ Clinical Research Organization (CRO) experience with therapeutic specialties preferred ・ Working knowledge of financial budgets and various financial analysis tools preferred ・ Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet ・ Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills ・ Ability to establish effective relationships with clients as well as team members ・ Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment ・ Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment |
| アピールポイント | 自社サービス・製品あり 外資系企業 女性管理職実績あり 上場企業 従業員数1000人以上 2年連続売り上げ10％以上UP 年間休日120日以上 産休・育休取得実績あり 教育・研修制度充実 資格支援制度充実 社内公用語が英語 シェアトップクラス 管理職・マネージャー 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 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2025/04/09 |
| 求人番号 | 4487229 |
採用企業情報
- サイネオス・ヘルス・ジャパン株式会社 クリニカル事業部
-
- 会社規模非公開
- CRO
- その他
-
会社概要
【代表者】スティファン・グトウ
【本社所在地】東京都千代田区丸の内2-7-2 JPタワー12階
【事業内容】医薬品及び医療機器に関わる臨床開発の受託事業
【当社について】
サイネオス・ヘルスは、業界で唯一、横断的なバイオ医薬品ソリューションを提供する会社です。私たちは、現代のマーケットの期待に応えようとするお客様に対し、お客様のパフォーマンスがより加速することを支援する、医薬品開発受託機関(CRO)およびコマーシャルビジネス受託機関(CCO)です。業界をリードするINC ResearchとinVentiv Healthの2社の合併によって設立された弊社は、クリニカル事業とコマーシャル事業の知識と経験を備えた28,000人以上の社員を、世界110カ国以上の拠点に擁し、皆様をサポート致します。
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