Director, Global DS&PV Physician
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Job Summary
About Us Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.
The Role
- 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
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
- 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
- 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
Other Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 20.9.2019, men kan have været deaktiveret og genaktiveret igen.
- Afdelingsleder
- København
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