Genmab A/S
Senior Director, Global Drug Safety & Pharmacovigilance Physician
Genmab A/S, Princeton, New Jersey, us, 08543
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.
Reporting to the VP, Head of Global Drug Safety & PV, the Senior Director, Global Drug Safety & Pharmacovigilance Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for the 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.
Responsibilities
Ensure individual health care safety and welfare of individual patientsInform global safety strategy and overall safety profile across assigned Genmab products.Lead a team of safety physicians and provide strategic guidance and mentorship.Direct all critical pre- and post-marketing safety related activities across lifecycle of assigned products.Lead collaboration and communication with drug safety and cross-functional teams for safety assessment and ongoing surveillance for assigned products.Oversee the medical assessment/review of patient individual Adverse Event reports from different sources for Genmab medicinal productsEnsure handling of safety issues and implementing risk mitigation activitiesOversee the medical safety review for documents e.g. Trial Protocols and amendments, Trial Reports, Trial plans, eCRFs/CRFs, TMFs, Investigator's Brochures, Subject Informed Consent, Development Safety Update Reports, periodic safety update reports, Integrated Safety Summaries and scientific articlesCommunicate any changes in the medicinal product risk profile internally and externally.Interface cross-functionally at all levels in the organization as well as with external Regulatory AuthoritiesCollaborate 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.Requirements
• MD required; clinical research and/or fellowship training in oncology/hematology, pharmacology or other relevant specialty is a plus
• Minimum 10 years Drug Safety/Pharmacovigilance experience 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)
• 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 Microsoft Excel, PowerPoint, and Word
• Experience leading a team of physicians
For US based candidates, the proposed salary band for this position is as follows:
$206,250.00---$343,750.00
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 You
You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatmentYou bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with diverse backgroundsYou are determined to do and be your best and take pride in enabling the best work of others on the teamYou are not afraid to grapple with the unknown and be innovativeYou have experience working in a fast-growing, dynamic company (or a strong desire to)You work hard and are not afraid to have a little fun while you do so
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Reporting to the VP, Head of Global Drug Safety & PV, the Senior Director, Global Drug Safety & Pharmacovigilance Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for the 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.
Responsibilities
Ensure individual health care safety and welfare of individual patientsInform global safety strategy and overall safety profile across assigned Genmab products.Lead a team of safety physicians and provide strategic guidance and mentorship.Direct all critical pre- and post-marketing safety related activities across lifecycle of assigned products.Lead collaboration and communication with drug safety and cross-functional teams for safety assessment and ongoing surveillance for assigned products.Oversee the medical assessment/review of patient individual Adverse Event reports from different sources for Genmab medicinal productsEnsure handling of safety issues and implementing risk mitigation activitiesOversee the medical safety review for documents e.g. Trial Protocols and amendments, Trial Reports, Trial plans, eCRFs/CRFs, TMFs, Investigator's Brochures, Subject Informed Consent, Development Safety Update Reports, periodic safety update reports, Integrated Safety Summaries and scientific articlesCommunicate any changes in the medicinal product risk profile internally and externally.Interface cross-functionally at all levels in the organization as well as with external Regulatory AuthoritiesCollaborate 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.Requirements
• MD required; clinical research and/or fellowship training in oncology/hematology, pharmacology or other relevant specialty is a plus
• Minimum 10 years Drug Safety/Pharmacovigilance experience 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)
• 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 Microsoft Excel, PowerPoint, and Word
• Experience leading a team of physicians
For US based candidates, the proposed salary band for this position is as follows:
$206,250.00---$343,750.00
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 You
You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatmentYou bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with diverse backgroundsYou are determined to do and be your best and take pride in enabling the best work of others on the teamYou are not afraid to grapple with the unknown and be innovativeYou have experience working in a fast-growing, dynamic company (or a strong desire to)You work hard and are not afraid to have a little fun while you do so
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.