Associate Director, Safety Physician
Genmab
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。
Position Summary:
The position is responsible for providing medical insight from drug safety perspective on clinical trials and post-marketing condition for Genmab product. In collaboration with global Drug Safety & PV and global safety physicians, he/she manage all safety related matters complying with the Japan and global safety requirements.
Primary roles & responsibilities include:
Review the JRMP and ensure alignment with Core RMP. Review local Japanese label and ensure alignment with CCDS regarding precautions or safety related wording. Conduct medical review for required individual case safety report, Japanese periodic aggregate reports or responses to questions from external stakeholders including Japanese health authority and HCPs. Provide medical safety insight for study/program strategies and outputs on clinical trials and post-marketing surveillance. Collaborate with local CRAs , sales reps or MSL to clarify safety queries, etc.
Responsibilities will include, but are not limited to:
Perform medical review of Adverse Events reports for Genmab products.
Perform ongoing local surveillance of safety data from Genmab clinical trials and post-marketing safety data.
Ensure handling of safety issues
Perform medical review and provide input to in collaboration with global safety physicians e.g. Trial Protocols and amendments, Trial Reports, Trial plans, eCRFs/CRFs, TMFs, Investigator’s Brochures, Subject Informed Consent, Development Safety Update Reports, Integrated Safety Summaries, scientific articles and medical reviews.
Prepare aggregated reports and safety summaries in accordance with regulatory requirements.
Responsible for establishment and management of external Data monitoring Committees (DMCs) if applicable.
Chair and manage Genmab Safety Committees if applicable.
Conduct training of Genmab employees, CROs and Investigators if applicable.
Contribute to multidisciplinary project groups and provide input to clinical development programs as a member of Clinical Trial Teams and local Compound teams.
Interact with safety/clinical CROs, and perform sponsor oversight activities.
Collaborate with external experts and partners if applicable.
Ensure compliance with regulatory guidelines and internal procedures in order to be prepared for audits and inspections.
Participate in audit and inspection activities as relevant.
Required Skills
Minimum requirement: 2+ years experiences as safety physician or 2+ years experiences of Pharmacovigilance related activities in a pharmaceutical or biotech products company.
General knowledge of local aggregate reports (J-DSUR, J-PSR, Unlisted Non-Serious Adverse Reactions Reports) and J-RMP
General knowledge of clinical/ drug development and defining safety profile of a product.
Medical degree (e.g., Bachelor of Medicine in Japan) or the equivalent degree from a medical school listed in WHO World Directory of Medical Schools.
Proficient skills in scoping and planning departmental lead projects with timely delivery, and high-quality output & good communication.
Proficient skills in engaging with internal and external stakeholders.
English skills (intermediate business communication level or above)
Willingness to learn & grow new things, ie fast learner
Strong interpersonal & communication skills
Bring out-of-box thinking and will to make it happen
Proactive, constructive attitude & behavior, self-starter
Executions with strategies, attention to details
Valid permanent residency in Japan
Native level Japanese in verbal, reading, & writing
Optional background
Basic or advanced knowledge of local regulation regarding GVP, GPSP or GCP.
Experience conducting “Medical Review” for ICSRs in clinical studies or post-marketing for expedited reporting according to a company policies or global/local requirements.
Experience of safety lead in a local clinical studies or post-marketing product safety especially for oncology, hematology area or antibody products.
Experience of any regulatory inspection or company audit as a departmental/functional contact person
Experience of authoring safety risk management plan or periodic reporting.
#LI-DNP
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。