Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

====(Japanese)====

業務内容

• 市販および開発中の製品に関する有害事象データの収集活動を支援しながら、ファーマコビジランス(安全性監視)および品質に関する計画・プロセス・方針を実行。これらはGLP(適正試験実施基準)および国内外の規制に準拠して、研究開発の品質を判断するためのものです。
• 有害事象に関するプロセスおよびデータベースの導入/運用。
• 臨床開発プログラムに対して統合的な安全性戦略を提供するため、ファーマコビジランスおよび品質計画のアライン・実行。
• 製品ライフサイクル全体を通じて、社内外の関係者に対して高品質な製品安全性データおよび分析結果提供。
• すべての製品に関する新たな安全性プロファイルを定義するため、安全性シグナルの迅速な特定・分析を通じてファーマコビジランスのプログラムと方針の策定。
• 創薬および前臨床開発プログラムに使用されるデータの品質と正確性管理。
• 品質監査プログラムへの参加。

差別化要素(Differentiator)

• 高度な教育と実務経験を通じて専門性を確立した職務領域のエキスパート
• 大規模かつ複雑なプロジェクトを管理し、エンドツーエンドのプロセスを独立して遂行(上司の監督は不要または限定的)
• プロセス改善や設計のイニシアティブを主導し、広い視野で複雑な課題に対する解決策を導出
• 社内外のビジネス課題を解釈し、最適な解決策やベストプラクティスを提案
• 通常、M3またはM4レベルの管理職に報告
• このレベルへの昇格は、ビジネスニーズに基づいて制限されることがあります

管理責任(Management Responsibility)

• 重要な専門分野における個人貢献者としての役割を担う。場合によっては、外部コンサルタントなどを含む2名以下の従業員を管理することもあります
• 管理対象がいる場合でも、業務の一部を共有する程度であり、プロジェクトの大部分を委任することは少ないです
• 若手社員の業務指導、トレーニング、レビュー、またはプロセス・プログラムの管理を行うことがあります
• 若手社員の育成や業務レビューを担当することもあります

ステークホルダー対応(Stakeholders)

• 他の専門部門や外部サービス提供者と連携し、影響を与える
• 新しい概念や手法の受け入れを促すことがあります
• 経営層や社内委員会向けのプレゼンテーションや提案資料を作成
• Galderma社のマネージャーとの信頼関係を構築
• 顧客や主要ステークホルダーの関心や懸念を理解し、適切な解決策を提供
• ラインマネージャーや従業員に対して技術的な指導を行う

経験レベル

8〜12年程度の実務経験

学歴

修士号または学士号、もしくはそれに相当する経験・資格

====(English)====

Career Stream Tasks

• Implement Pharmacovigilance & Quality plans, processes and policies while supporting the activities of collecting adverse event data on all marketed and in development products and determining quality of R&D studies in accordance with Good Laboratory Practices (GLP) and local and international regulations
• Implement adverse event processes and databases
• Align and implement Pharmacovigilance & Quality plans to provide integrated strategic safety expertise to clinical development programs
• Reconcile and process high-quality product safety data and analysis to internal and external customers throughout the product life cycle
• Implement and execute programs and policies of pharmacovigilance with rapid identification and analysis of safety signals to define emerging drug safety profiles of all products and drive patient risk management
• Administer all activities to control the quality and accuracy of the data used in drug discovery and preclinical development programs
• Participate in quality audit programs and ensure their implementation

Differentiator

• Professional who is an established subject matter expert within a job area typically obtained through advanced education and work experience
• Manage large & complex projects and/or owns end-to-end processes, working independently with no supervision or only limited supervision from manager
• May lead process improvement and process design initiatives. takes a broad perspective to identify solutions as problems faced are often complex
• Interprets internal or external business issues and recommends solutions/best practices
• Typically Reports to M3/M4
• Progression to this level is typically restricted on the basis of business requirement

Management Responsability

• Individual contributor accountable for an important subject-matter area/discipline. May sometimes manages two or fewer employees including outsourced / project-based contingent workforce (i.e. external consultants)
• When managing employees the responsibility is mostly related to sharing his/her work across one or two other individual collaborators instead of delegating significant parts of projects
• May direct the work, train or mentor junior employees or manage processes and programs
• Coach and review the work of junior employees

Stakeholders

• Connect with and influence other specialist departments and external service providers
• May convince others to accept new concepts, practices, and approaches
• Prepares presentations and concepts to be presented to leadership and company committees
• Build strong, trusting cross-functional relationships with Galderma managers
• Understand customer and key stakeholders interests and concerns and guide and provide solutions to customers and key stakeholders
• Provide technical guidance to line managers and employees

Experience Level
8 -12 years

Education Level
Master's / Bachelor's Degree or equivalent experience/qualification