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Contractor - Manager, Global Drug Safety & PV Safety Operations
3 months ago
Contractor - Manager, Global Drug Safety & PV Safety Operations Location: Princeton, NJ Posted: 5 Days Ago Job Requisition ID: R11169 Contract Position - 6 months - Hybrid Role A member of the Global Drug Safety & Pharmacovigilance team, focused on safety operations including but not limited to the collection and processing of safety information from various sources, quality control of safety data entry, regulatory submission of individual cases safety reports (ICSRs), and case exchange with business partners. Key Responsibilities: Perform quality control of safety case data entry to ensure compliance with data entry conventions and coding conventions. Support management of daily safety case workload ensuring compliance with regulatory submissions and internal timelines. Provide guidance on Safety Operations based on company conventions, ICH, and regulatory guidance. Ensure reporting destinations are correctly populated for each safety case and approve regulatory reports. Monitor and triage email communications received in Safety Operation Mailboxes. Review and provide input on study-specific documents. Support set-up and maintenance of study-specific activities. Perform reconciliation with stakeholders to ensure cases are exchanged as per agreements. Analyze reasons for late submission/distribution of safety reports. Contribute to creation or updating of SOPs, Working Instructions, and training materials. Participate or support Genmab initiatives and projects on Safety Operations behalf. Other activities as requested by supervisor. Skills and Experience Drug Safety professional with minimum 3 years of experience within drug safety and PV inclusive of case quality control and regulatory submissions of ICSRs worldwide. Bachelor’s/Master’s degree in science. Knowledge of ICH E2B(R2) and (R3) specifications and entry guidance. Experience with clinical and/or post-marketing case processing, including coding and narrative writing. Experience with safety database; Argus is a plus. Experience with EDC for clinical trial data collection is a plus. Excellent in detailed-oriented tasks. About You You are passionate about our purpose and care about transforming the lives of patients through innovative cancer treatment. You bring rigor and excellence to all that you do. You are a generous collaborator who can work in teams with diverse backgrounds. You are determined to do and be your best. You are not afraid to grapple with the unknown and be innovative. You have experience working in a fast-growing, dynamic company. You work hard and are not afraid to have a little fun. Locations Genmab leverages an agile working environment for employee work-life balance. Our offices are designed as open, community-based spaces that connect employees while being immersed in state-of-the-art laboratories. About Genmab Genmab is an innovative biotech company founded in 1999 in Copenhagen, Denmark. Our product pipeline and technologies are a result of our strong company culture, passion for innovation, and desire to transform cancer treatment and serious diseases. Our commitment to diversity, equity, and inclusion We are committed to fostering workplace diversity and believe it is essential for our success. No applicant shall be discriminated against. Learn more about our commitments on our website. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy on our website. #J-18808-Ljbffr
