セーフティー・フィジシャンの求人一覧

medical review of adverse events for investigational and marketed drugs in compliance

仕事内容

The Global Patient Safety (GPS) Global Medical Review, Advisor, and Senior Advisor role is responsible for medical review of adverse events for investigational and marketed drugs in compliance with the Pharmaceutical Affairs Law, Good Vigilance Practice (GVP), Good Post-Marketing Study Practice (GPSP), Good Clinical Practice (GCP), Standard of Operating Procedures (SOP), and Safety and Efficacy Quality System-Safety (SEQSS) in Japan. This includes medical review of individual case safety reports (ICSRs) of investigational and marketed drugs; maintaining awareness of Japanese and global pharmacovigilance regulations; ensuring regulatory compliance for expedited submission of individual case reports; collaborating with internal and external business partners; as well as other duties as assigned. The Medical Reviewer provides leadership for Global Patient Safety (GPS) Safety Management, Reporting and Safety Data Sciences (SMRD) and guidance to case managers, as appropriate.

Primary responsibilities:

Medical Support of Adverse Event Reporting Process
・Provide the medical and clinical expertise to support the management and evaluation of ICSRs and their assessment for reporting.
・Work closely with the other Regional Medical Reviewer(s), Global Medical Reviewers, Case Management, personnel, and the GPS Medical physicians and scientists (global and Japan) to ensure appropriate communication and the medical quality of ICSRs.
・Keep updated on global regulatory issues and practices related to pharmacovigilance activities in Japan.
・Assist in supporting customer response activities associated with adverse events.

GPS Medical Leadership
As a medical role of GPS for spontaneously reported and clinical trial individual case safety reporting, contribute to the global assessment of safety of products and molecules in clinical trials by interacting directly or indirectly with the GPS Medical physicians and scientists and Safety Surveillance Teams (SSTs) and Japan Safety Management Teams (SMTs) involved in assessing the safety profile of products. This responsibility may require involvement in discussions related to management of marketed products and developmental product safety with the above team members.

Participate in process development, quality review, continuous inspection and audit preparedness and inspection/ audit support, and similar activities in response to a changing regulatory environment or corporate priorities.

Act as the GPS Medical Review representative for both internal and external customers, interacting as prescribed in corporate guidelines and policies.

Build strong relationships with key customers, representing and championing the role of safety in the organization.

As appropriate, provide leadership for Safety Management, Reporting and Safety Data Sciences (SMRD). This leadership might be provided through technical and/or administrative oversight of global case management activities, what includes providing technical excellence; identifying functional resources and building knowledge of pharmaceutical industry; identifying and communicating areas for scientific and process improvements and participate in change within the organization; creating an environment wherein training and mentoring is valued; and facilitating the training of other Medical Reviewers. in the responsibilities of the role, as needed.

Understand the roles and responsibilities of the European Union Qualified Person Responsible for Pharmacovigilance (QPPV) and support the QPPV role. Other job expectations

・Maintain compliance with all assigned training.
・Develop Global Patient Safety expertise through discussion and training programs.
・Drive safety related training programs and presentations.
・Support Japan GPS Medical Reviewer(s) in the Principal, Senior Principal role

・Meet the R&D Titles Expectations as outlined in the R&D Titles Framework. Maintain medical expertise in areas of interest or specialty.
・Understand and comply with all compliance policies, laws, regulations, and the Red Book.
・Adapt to the changing global regulatory environment.
・Understand the confidential nature of company information and take necessary steps to ensure its protection.

応募条件

【必須事項】

・Advanced medical related graduate degree, such as: M.D., DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 1-3 years of experience in related scientific field, e.g. Pharmacology, physiology, microbiology or scientifically related field.
　　　OR

・BS degree in a health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, Pharmacovigilance, regulatory affairs.
　　　OR

・3-5 years of clinical experience, or 3-5 years of pharmaceutical experience, at least 2 years of which was clinical development experience.
・Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
・Effective communication skills (Japanese and English, verbal and written) to respond effectively to customer requirements and requests.

【歓迎経験】

・Facility in the use of computer-related tools essential (e.g. word processing, e-mail, web browsers)
・Ability to work in a global environment (virtual tools)
・Leadership (i.e. working autonomously, influencing without authority, ability to network ideas in corporate environment.)
・Knowledge of pharmacoepidemiology

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】在宅可、兵庫、他

年収・給与

経験により応相談

医師を活かしメディカルドクターとしてMA、臨床開発、安全管理部とご経験に応じて担っていただきます。

仕事内容

◇ 医薬安全管理部
・国内個別症例のメディカルレビュー、クエリー作成等 ※最優先業務
・シグナル検出、集積評価に関するアドバイス
・RMP 作成・改訂に関するアドバイス
・開発品目の申請対応における WG へのアドバイス（「使用上の注意」、RMP）
・その他、安全性に係る課題に対するアドバイス
・グローバル販売品目について、米国 MD との意見交換

◇ 国際事業部
・現地パートナー（導出先）を通じて寄せられる海外医師からの QA 対応

◇ メディカルアフェアーズ部
・各担当チームによるメディカルプラン策定に関するアドバイス
・各品目・領域の臨床研究、データベース研究、レジストリ研究の企画・立案に関するアドバイス、教育
・各品目・領域の臨床研究、データベース研究、レジストリ研究の実行・推進・論文作成等に関するアドバイス、教育

◇ 臨床開発部
・治験におけるメディカルモニタリングに関する相談
・臨床データパッケージ等、国内外規制当局相談に向けた戦略に関する相談
・製販後調査計画の立案時に安全性検討事項・RQ の適切性、調査項目等の適切性の
相談
・製販後調査結果の考察・解釈に関する相談

応募条件

【必須事項】

・医薬部出身、医師免許あり

◇ 医薬安全管理部
・当社製品領域（血液、肺高血圧、筋ジストロフィー等）に関する医学的知識・経験
・国内外の関係者との日本語／英語によるコミュニケーション能力

◇ メディカルアフェアーズ部
・医師免許及び豊富な臨床経験
・当社製品領域（血液、肺高血圧、筋ジストロフィー、てんかん）に関する医学的知識・経験
・臨床研究法、人を対象とする生命科学・医学系研究に関する倫理指針についての知識
・国内外のKEEとのコミュニケーション能力（日本語・英語）
・友好な対人関係構築力及び優れた交渉力

◇ 臨床開発部
・治験における有効性・安全性に関する医学的見地からのアドバイスの経験
・製販後調査における有効性・安全性に関する医学的見地からのアドバイスの経験

【歓迎経験】

◇ 医薬安全管理部
・国内外のファーマコビジランス関連法令に関する知識・経験

◇ メディカルアフェアーズ部門
・製薬企業での就業経験

【免許・資格】

【勤務開始日】

応相談

勤務地

【住所】京都

年収・給与

経験により応相談