Pharmacovigilance Scientist

メルクと一緒に、あなたの力を発揮しよう！  
 
冒険、限界への挑戦、そして発見に焦がれるあなたへ。あなたの大志を、メルクで羽ばたかせましょう！科学とテクノロジーを駆使したイノベーションに情熱を注ぐメルクのスタッフは世界中で活躍中です。ヘルスケア、生命科学、エレクトロニクスの分野で、メルクのソリューションは人々の暮らしをますます豊かなものにしています。あなたとメルクの力を合わせて、大きな夢を抱きましょう。メルクは、人、顧客、患者、そしてこの地球という惑星が共存する豊かな世界の構築に情熱を注いでいます。このためメルクでは、好奇心にあふれた人材を募集中です。メルクと一緒に、想像を超えた世界を開拓しませんか？  

患者さんのためにひとつになって団結し、生命の誕生、QOLの向上、命をつなぐサポートをすることか、ヘルスケアにおける私たちの目的です。私たちは、腫瘍学、神経学、不妊治療などの疾患領域において、医薬品、インテリジェント装置、革新的技術を開発します。私たちのチームは、人生のすべてのステージで患者さんを助けるために、情熱と執拗な好奇心を持って6大陸全体で協力して働いています。ヘルスケアチームに入ることは、多様的で包含的、そして柔軟な職場文化の一部となることです。世界中で個人的な能力開発とキャリアアップの素晴らしいチャンスが待ち受けています。

Job Title: Pharmacovigilance Scientist, Global Patient Safety Japan

Location: Tokyo, Japan

Report To: Safety Strategy Lead Japan

Direct Reports: None

Your Role:

The purpose of this role is to support the GPS safety strategy lead Japan in order to provide integrated medical safety strategies for the assigned investigational and marketed products. This includes input into safety aspects of clinical development, risk management and benefit-risk management for assigned products.

Support preparing dossiers submitted to Japanese Health Authorities:

l  Support Safety Strategy Lead Japan to prepare Safety parts in submission dossiers (CTD 2.7.4, etc ) collaborating with Safety Strategy Lead in Japan, GPS at HQ and other functions in R&D-Japan.

l  Prepare and coordinate local & global review for the Japanese periodic safety reports; safety parts in J-PBRER,  unlisted/non-serious ADR reports, medical device unknown non-serious defect periodic report and J-DSUR

l  Prepare re-examination application dossier

l  Support Safety Strategy Lead Japan to draft responses to inquiries from PMDA, and finalize collaborating with Global

l  Draft and review coordination of local study reports and reports of safety measure, which could be launched and/or development product.

Signal detection and management:

l  Conduct basic signal detection activities like case triage, medical assessment for Japan cases.

l  Reviewing reports and data in dedicated tools (e.g. Spotfire, EVDAS, Empirica Signals, as applicable) for signal detection purposes for Japan data considering the Japanese regulatory requirements for data of Japan

l  Reviewing and assessing clinical and safety database output of Japan data; medically/scientifically analyzing and interpreting aggregate safety data from clinical trials and post-marketing sources of Japan to evaluate potential signals/issues 

l  Reviewing the scientific Japanese literature (non-ICSR literature) for safety surveillance and signal detection purposes

l  Supporting the analysis of safety signals originated from Japan (including contributions to the signal evaluation report, and BRAT, PVAB, MSEB and LDB meeting contributions)

l  Emerging Safety Issue Reports: supporting the communication to external stakeholders in Japan

Benefit/Risk Activities:

l  Supporting the definition of the safety profile including the definition of important risks/safety concerns specific to Japan

l  Supporting the delivery of Japan specific content related input into the core benefit-risk document and associated documents

l  Contribute with Japan specific safety related information that can be relayed at wider program meetings (e.g. GPT, BRAT, PVAB etc )

 (d)RMP (updates) and periodic safety reports:

l  Supporting in developing Japan specific part in RMP (if applicable) and implementing RMPs, including risk minimization measurers with quality, efficiency and timeliness.

l  Support the local adaption of RMPs

l  Supporting the delivery content related input into periodic safety reports by the following involvement but not limited to

·         Author the simple sections of the aggregate safety report(s), e.g. PBRERs, PSURs DSUR

·         Contribute to moderate complexity level sections of above mentioned the report(s), e.g. in relation to BR, Signals, etc

·         Analyze data from different sources and input relevant data to the report(s)

Safety input into regulatory filings and associated submission activities:

l  Contribute with data and evidence needed for regulatory filings, e.g. risk management plan, briefing book，ISS/SCS IAP, Modules 2.7.4 and 2.5, RMP and product information

l  Providing content related safety input into Clinical Overview Addendum

Clinical trial activities:

l  Supporting the delivery of content related input into the safety sections of the IMPD, IB and ICF

l  Supporting the delivery of safety related input into the development of other clinical trial related documents such as clinical trial protocols, integrated analysis plan, clinical trial reports

l  Providing safety related input for data monitoring committees (i.e. charters, meeting minutes)

Inspection/Audit Management:

l  Explore findings appropriately to determine whether they are signs of underlying issues or isolated events

l  Participate in audit/inspection interviews for medical safety questions of specific products

l  Providing responses to queries from auditors/inspectors

l  Be a trusted point of contact for drafting CAPA response for BR-related topics all for CAPA process

Other activities:

l  Developing and maintaining MedDRA CMQs for the analysis of potential signals and aggregate safety data

l  Developing product-specific trainings for internal or external stakeholders

l  Providing expert input into the standardization and improvement of processes within GPS.

Interfaces with other Departments/Functions:

l  Internal GPS sub-functions

l  Other functions such as Translational Medicine, GCD, GBEM, Program Leadership and GCO, GRA, GMA, R&D QA, Medical Information, Communication and Business Units

l  Global Product Teams, Submission Teams

External Interfaces:

l  Consulting experts

l  CROs

l  Regulatory Agencies

l  Co-development/business partners

Who you are:

Required professional experience and necessary training:

l  MD, Pharmacist or PhD/advanced science degree.

l  Native in written and spoken Japanese.

l  Fluent in written and spoken English.

Necessary professional experience:

l  MD: Clinical experience (preferably ≥ 2 years); Pharmacist, PhD/advanced science degree: pharmaceutical industry experience (preferably ≥ 5 years) in an affiliate setting preferably in R&D organization or similar (e.g. Health Authority)

l  Advanced experience in Pharmacovigilance (preferably both in the clinical development as well as the post-marketing area)

l  Experienced in working in cross-functional, global teams, across different regions.

Required technical skills:

l  Advanced understanding of the end to end drug lifecycle and basic knowledge of the drug development process

l  Advanced knowledge of relevant regulation

l  Advanced knowledge of interpreting individual cases and aggregate safety data

l  Advanced understanding of the current approaches to benefit risk and signal management

l  Demonstrated ability to author scientific reports

Required personal skills:

l  Strong team player and excellent networking skills.

l  Solution and results oriented.

l  Ability to work in intense, fast-paced, multi-national environment, to cope with resistance and solve problems.

l  Demonstrated ability to work under pressure and achieve strict timeline targets.

l  Embraces change and adapts to changing environments

l  Excellent verbal and written communication skills (in English language).

私たちが提供するもの：私たちは、さまざまな背景、視点、人生経験を持つ好奇心旺盛な人々で構成されるグループです。この多様性が卓越性と革新を促進し、科学と技術のリーダーシップを強化すると信じています。私たちは、すべての人が自分のペースで成長し発展するためのアクセスと機会を創出することにコミットしています。何百万もの人々に影響を与え、誰もが人類の進歩を支持できるようにする包括性と帰属感のある文化を築くために私たちに参加してください！

今すぐ応募して、発見を促し、人類の発展を高めることに専念するチームの一員になりましょう！