PV Scientist / Biopharma (Tokyo)

Merck
Posted on

Type

Mid-level industry position

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

[English Follows]

現体制では治験、承認申請関係の対応において実務としてSSLを支援できることが重要になります。

特に申請業務の経験(申請資料の作成、当局とのコミュニケーション[交渉]、照会事項対応の経験)は必須となります。

上記以外に期待する主な業務

  1. 市販後に発生する安全性の報告書作成(定期報告・その他)
    • データハンドリングも含む(データマネジメントの知識があれば尚よし)
    • 関係者へのレビュー依頼や記録の保存も行う(システムの取り扱いなどを厭わない人)
  2. 医療関係者からのクエリ対応(Call center/MECからの依頼)
    • 必要なデータの抽出
    • Call center/MECと協力して必要な回答を作成
  3. 手順書・マニュアルの作成
    • Global R&Dのルールに従ったADDを管理する
    • その他、必要な手順を文書化する

The purpose of this role is to support the GPS safety strategy leads 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.

Key responsibilities of the Pharmacovigilance Scientist within Safety Science include (but not limited to):

Preparing dossiers submitted to Japanese Health Authorities:

  • 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.
  • Prepare safety parts in J-PBRER and Re-examination application dossier
  • Draft responses to inquiries from PMDA, and finalize collaborating with Global
  • Make periodic reports, such as J-DSUR, Unlisted/Non-serious ADR reports.

Clinical trial activities

  • Supporting the delivery of content related input into the safety sections of the IMPD, IB and ICF
  • 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
  • Providing safety related input for data monitoring committees (i.e. charters, meeting minutes)

Signal detection and management:

  • Conduct basic signal detection activities like case triage, medical assessment for Japan cases.
  • 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
  • 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
  • Reviewing the scientific Japanese literature (non-ICSR literature) for safety surveillance and signal detection purposes
  • Supporting the analysis of safety signals originated from Japan (including contributions to the signal evaluation report, and BRAT, PVAB, MSEB and LDB meeting contributions)
  • Emerging Safety Issue Reports: supporting the communication to external stakeholders in Japan

Benefit/Risk Activities:

  • Supporting the definition of the safety profile including the definition of important risks/safety concerns specific to Japan
  • Supporting the delivery of Japan specific content related input into the core benefit-risk document and associated documents
  • 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

  • Supporting in developing Japan specific part in RMP (if applicable) and implementing RMPs, including risk minimization measurers with quality, efficiency and timeliness.
  • Support the local adaption of RMPs
  • 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

  • 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
  • Providing content related safety input into Clinical Overview Addendum

Inspection/Audit Management

  • Explore findings appropriately to determine whether they are signs of underlying issues or isolated events
  • Participate in audit/inspection interviews for medical safety questions of specific products
  • Providing responses to queries from auditors/inspectors
  • Be a trusted point of contact for drafting CAPA response for BR-related topics all for CAPA process

Other activities

  • Developing and maintaining MedDRA CMQs for the analysis of potential signals and aggregate safety data
  • Developing product-specific trainings for internal or external stakeholders
  • Providing expert input into the standardization and improvement of processes within GPS.

WORK EXPERIENCE

Necessary professional experience

  • MD: Clinical experience (preferably ≥ 2 years); 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)
  • Advanced experience in Pharmacovigilance (both in the clinical development as well as the post-marketing area)
  • Advanced understanding of internal medicine, general medicine, epidemiology, pharmacology, Oncology/ Haematology
  • Experienced in working in cross-functional, global teams, across different regions.

JOB-SPECIFIC COMPETENCIES & SKILLS

Required technical skills

  • Advanced understanding of the end to end drug lifecycle and basic knowledge of the drug development process
  • Advanced knowledge of relevant regulation
  • Advanced knowledge of interpreting individual cases and aggregate safety data
  • Advanced understanding of the current approaches to benefit risk and signal management
  • Demonstrated ability to author scientific reports

Required professional experience and necessary training

  • Advanced science degree.
  • Fluent in written and spoken English.

Recruiting Contact: Nozomu Yokota

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

More Information

Posted on

Type

Mid-level industry position

Tokyo%2C%20JP%2C%20Tokyo%2C%20Japan

Tokyo, JP

Tokyo , Japan