【Abbott Medical Japan】Safety Specialist
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Job Summary/職務概要: Briefly state the main purpose and scope of the job.
市販後安全管理業務
Job Duties/職務内容: List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform.
国内、文献、感染症に関する安全管理情報の収集、検討、評価及び行政報告の期限内（ 15 日／ 30 日） の提出
上記追加情報の入手及び、海外製造元からの問い合わせへの回答
苦情報告及び現品返送の期限の遵守
外国症例、外国措置に関する安全管理情報の収集、検討、評価及び行政報告の期限内（ 15 日／ 30 日） の提出
顧客レターの作成、顧客レターに関する問い合わせ、顧客同行
新規添付文書のレビュー、添付文書改訂案の作成、改訂スケジュール管理
取扱説明書、マーケティングツールのレビュー
製品導入前リスクアセスメント
安全確保措置の立案、関連部署への指示（回収（改修、患者モニタリング）、情報提供等の計画策定、安全確保措置に必要な指示書、情報提供文書等の文書の作成および関連部署への作成指示、情報提供／患者モニタリングの進捗管理）
国内の市販後における不具合の傾向分析及び関連部門（製造元を含む）との連携、品質維持に必要な措置の立案および実施他部門との連携（製品上市時、 FCA 時、プロジェクト等）
安全管理業務に関連する外注先の管理 (添付文書、外国措置情報、文献情報 等）
プロセス改善や新規プロセス立ち上げ等のプロジェクトに対する積極的な参加
Sr. Specialist の場合は、上記に加え、メンバーの指導的立場となり、処理能力の面でも Specialist 以上であること。
Qualifications/能力資格要件: Describe the minimum education and experience, including knowledge, skills and abilities, required to successfully perform the job. List any certificates, license, and/or registrations required.
簡潔に文章／資料をまとめ、分かりやすい資料を作成することができる。
国内関係部門と連携し、上司の指示のもと調整ができる
複数の業務について優先順位を付け、期限通りに業務を完了できる
英文読解並びにメールや口頭で製造元とコミュニケーション又は交渉ができる。
分析結果を理解する技術的な基礎知識があり、顧客に説明する能力を有する。
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1369 comparable Quality roles across 143 biopharma companies.
Salary context
230 of 1369 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1369 comparable roles
+ 46 more countries
Seniority mix
625 of 1369 peers have a known seniority level
Therapeutic area mix
1 of 1369 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.