Genmab
Location
Princeton, NJ | United States
Job description
At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Drug Safety & Pharmacovigilance (GDS&PV) Physician role is a safety expert medical role contributing to the global safety strategy and overall safety profile for the assigned Genmab products (mainly investigational) throughout their lifecycle. As our Director, you must effectively interact cross-functionally at all levels in the organization, as well as with external parties, including Regulatory Authorities, as applicable. The role reports to the Vice President MD, Team Lead. You will work together with other Drug Safety 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 supporting the Team Lead. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential. This position has a global perspective, and you will interact with stakeholders ranging from regulatory authorities and Data Monitoring Committees as well as colleagues from other Genmab sites. As Director, GDS&PV Physician, you will be part of a highly skilled and international team and you will act as a GDS&PV ambassador cross company- e.g., by explaining and training on PV principles. Importantly, you are also expected to mentor more junior colleagues, and help them reach their best. Responsibilities: • Lead all major pre- and post-marketing safety-related activities including signal, benefit-risk evaluation and risk management activities for own area • Effectively collaborate with drug safety and cross-functional teams for safety assessment (e.g. review of AEs and scientific literature; safety reports), ongoing surveillance, and related communication around assigned Genmab products • Oversee handling of safety issues and implementing risk mitigation activities, and propose systemic solutions • Provide inputs to different documents (e.g. trial protocols, amendments and plans; clinical trial reports; eCRFs/CRFs;TMFs) based on review • Prepare relevant documentation (e.g. benefit/risk sections of aggregate reports; safety summaries) as per regulatory requirements • Manage internal & external forums (e.g. external Data monitoring Committees (DMCs); Genmab Safety Committees) for assigned products • Provide guidance, oversight, and training around safety to relevant stakeholders (e.g. Genmab employees, CROs, Investigators) • Proactively engage with internal stakeholders (e.g. multidisciplinary project groups) and external stakeholders (e.g. external experts and partners around emerging landscape; regulatory authorities around audits and inspections) • Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations Requirements: • MD required • Minimum requirement: 12+ years experience in in drug safety/pharmacovigilance in clinical development and post-marketing preferably in oncology • Experience with PV audit process with active participation in Regulatory Authority Inspections; and working with the FDA and other regulatory authorities • Experience with global PV regulatory environment (regulations, initiatives, standards, GVP); MedDRA and WHODrug coding dictionaries; and individual adverse event case report processing, triage and medical review • Experience with safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems preferred • Experience guiding and mentoring team members • Proven performance in earlier role/comparable role For US based candidates, the proposed salary band for this position is as follows: $170,625.00---$284,375.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses. About YouJob tags
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