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.

 Key Accountabilities

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