Senior Director/Director Drug Safety Physician
Senior Director/Director Drug Safety Physician
THIS POSITION CAN BE BASED EITHER AT OUR US SITE IN PRINCETON, NJ OR IN DENMARK!
Reporting to the VP, Head of Global Drug Safety, the Drug Safety Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for his assigned Genmab products (investigational) throughout their lifecycle. This includes leading all major pre- and post-marketing safety related deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with other Drug Safety (DS) staff in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.
Perform medical review of Adverse Events reports for Genmab products
Perform ongoing surveillance of safety data for Genmab products from different sources.
Ensure handling of safety issues and implementing risk mitigation activities
Perform medical review and provide input to different documents e.g. Trial Protocols and amendments, Clinical Trial Reports, Trial plans, eCRFs/CRFs, TMFs, Investigator’s Brochures, Subject Informed Consent, Development Safety Update Reports, Integrated Safety Summaries, scientific articles, etc.
Prepare benefit/risk sections of aggregate reports and safety summaries in accordance with regulatory requirements for assigned compounds
Responsible for establishment and management of external Data monitoring Committees (DMCs)
Chair and manage Genmab Safety Committees for his assigned products
Conduct safety training of Genmab employees, CROs and Investigators
Member of CMTs and CDTs, contribute to multidisciplinary project groups and provide input to clinical development programs
Interact with safety and clinical CROs and perform sponsor oversight activities
Collaborate with external experts and partners
Contribute to multidisciplinary project groups
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
Skills & Experience
MD required; medical licensure in at least one state preferred; clinical research and/or fellowship training in oncology/hematology, pharmacology or other relevant specialty is a plus.
Minimum 2-4 years Drug Safety/Pharmacovigilance experience (For Director level and more experience for Sr. Director level) plus 2 years clinical development experience; other relevant experience may be considered
Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP). including but not limited to Americas, European Union, Latin-America and Asia-Pacific territories
Exposure to working relationship with the FDA and other regulatory authorities is preferred
Strong knowledge of individual adverse event case report processing, triage and medical review
Working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems is preferred
MedDRA trained and working knowledge of MedDRA and WHODrug coding dictionaries
Working experience with PV audit process with active participation in Regulatory Authority Inspections
Ability to manage multiple tasks with deadlines in fast-paced working environment with demonstrated successful management of complex projects within the scope of this position
Excellent knowledge of drug development process
Requires a high level of initiative and independence
Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork
Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word
Some national/international travel may be required
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