Senior Manager, Safety Scientist

Hiring By - Biostaffic



Job Highlights

Not Disclosed

Posted 4 months ago
Job details
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

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • Japan

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 14, 2024
Company Overview

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 Disclaimer:
Are you an employee? 🌟
Explore Biotech Jobs

Find the one that suits your cosmic aspirations. Search open positions across the web, find opportunities uniquely matched to your skills, and read reviews on companies worldwide. 🚀💼🌎

Are you an employer? 🌟

Hire Top Talent in the Biotechnology Industry.

Post jobs, search for stellar candidates, and conduct the complete hiring process—all from your desktop or mobile phone. 🚀🔬👩‍🚀