The position is responsible for providing medical insight from drug safety perspective on clinical trials and post-marketing condition for Genmab products. In collaboration with global Drug Safety & PV and global safety physicians, he/she manages 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 sections. Conduct medical review for required individual safety case reports, Japanese periodic aggregate reports. Prepare/review responses to questions from external stakeholders including Japanese health authority and HCPs. At times, directly communicate with PMDA's medical officers or reporting physicians to gather appropriate information, enabling the assessment of necessary actions and responses for individual cases. 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. Identify the contents and specific items for follow-up attempts to reporting HCPs.
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.
Participating in audit and inspection activities as relevant.
Required Skills
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.
A minimum of 2 years of clinical practice experience.
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.
Japanese (Native level for verbal communication) /English skills (intermediate business communication level or above)
Competencies
Willingness to learn & grow new things, ie fast learner
Strong interpersonal & communication skills
Bring out-of-box thinking and will to make it happen
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 physician/scientist role or any pharmacovigilance related roles.
Experience of safety lead in a local clinical studies or post-marketing product safety especially for oncology, hematology area or antibody products.
Experience of medical director or clinical research scientist for clinical development and projects.
Experience of any regulatory inspection or company audit as a departmental/functional contact person.
Experience of authoring safety risk management plan or periodic reporting.
