Senior Manager, Safety Scientist

Hiring By - Biostaffic

 BioPharma

Japan

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。
Primary roles & responsibilities include:
Ongoing safety review at a case level and aggregate level in the clinical studies. Monitor/evaluate all risk minimization activities defined in the development phase program including special interest of AE. Contribute to J-CTD preparation, J-NDA submission and marketing approval joining J-NDA team as local safety representative. Lead/facilitate safety related topics including Japan Risk Management plan (J-RMP) M1.11 or safety part of Japanese Package Insert (J-PI). Oversight relevant safety vendors and maintain the contract or safety monitoring plan in the clinical studies. Prepare local aggregate safety reports including J-DSUR, J-PSR or periodic non serious unexpected ADRs reporting etc. Maintain J-RMP and appropriate safety measures including revision of J-PI, applicable patient support guidance/education materials for appropriate Genmab MAH product use in collaboration with relevant global/local departments and partners. Conduct and report periodic/ad-hoc aggregated local safety review and signal detection activities in collaboration with global counterparts. Understand all GVP, GPSP-related operations and gap with global requirements and procedures.
Minimum Requirements:
Bachelor of Science
5+ years of relevant experience in Pharmacovigilance/Clinical Research
Experience executing processes/projects in own area (e.g. developing documents as per regulations & reporting requirements; preparation of post-marketing/clinical trial safety assessments; regulatory submissions etc.)
Experience working with regulatory requirements, good clinical practices, and pharmaceutical clinical development
Experience communicating with Global team
  • Valid working visa or permanent residency in Japan
  • Native level Japanese in verbal, reading, & writing
私たちは、社員ひとり一人が共通の目的に向かって、高い志を持ち、お互いを尊重し、共通の価値観をもとに日々仕事をしています。私たちの価値観の一つである誠実さを胸に、革新的な抗体治療薬の創薬に一人ひとりが主体性をもち取り組んでいます。ジェンマブでは、がん患者さんの人生をより豊かにすることを目的に、部門や国境を超え、世界中の深い専門知識を有した仲間たちと共にがん治療の将来に変革をもたらすこれまでにない経験をしていただけると信じています。
互いを尊重して協力し合うチームワークは、ジェンマブの重要な企業文化であり、そのため世界中の社員が、インクルーシブ、オープン、協力しあう姿勢を大切に日々仕事をしています。地域、教育、文化、国籍、年齢、性別などを超えた多様性を推進し続けていくことが、企業が継続して成長していくために重要であると考えています。そのため採用においても、性別、年齢等に関わらず、スキルや能力をもとに多様性を重視し進めています。
ジェンマブ株式会社では、お客様の個人データ及びプライバシーを重要なものと認識しており、個人情報の保護に関する法律その他の関係法令を遵守しております。ご応募いただく際は、個人情報の取扱いにご同意いただいた上、ご応募ください。

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Japan

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview
Genmab
Genmab

Current Openings: 0

We are an international biotech company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, our passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, we have formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, our vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO®) antibody medicines. We are united by our core values: a passion for innovation, determination, integrity, and working as one team and respecting each other. When you work at Genmab you'll be part of a warm, fun, dynamic community seeking out and embracing the opportunity to build new and bold futures within a rapidly growing biotechnology company. Genmab is a place where you can be authentically you; you are empowered to innovate, build solutions and execute; you feel cared for and supported. In its totality, this makes working at Genmab an extra[not]ordinaryTM experience. Established in 1999, we are headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S., and Tokyo, Japan. For more information, please visit Genmab.com. Disclaimer: http://bit.ly/GENDisclaimer
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