Senior Director - Global Drug Safety & Pharmacovigilance

2 days ago

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Genmab

WebsiteLinkedInAll Job Openings

1001 - 5000

💰 $134M Post-IPO Equity on 2010-06

Description

• Ensure individual health care safety and welfare of individual patients • Inform 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 products • Ensure handling of safety issues and implementing risk mitigation activities • Oversee 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 articles • Communicate 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 Authorities • 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.

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