Senior Manager, Global Drug Safety Operations
2 weeks ago
We are seeking a highly skilled Senior Manager to join our Global Drug Safety and Pharmacovigilance team. As a key member of our team, you will be responsible for overseeing the successful and timely case intake of safety reports and case processing.
Key Responsibilities- Oversee the successful and timely case intake of safety reports and case processing
- Perform ongoing and real-time quality control review of safety case data entry in the safety database in compliance with the data entry conventions and MedDRA/WHO DD coding conventions
- Provide guidance on questions around safety operations based on not only company conventions, but also ICH and regulatory guidance as well as the best PV practices
- Develop or update Standard Operating Procedures, Working Instructions, and training materials around safety case processing and operations
- Oversee and manage SAE Reconciliation activities including review and approval of the reconciliation plan and generation of SAE reconciliation listings
- Effectively manage safety case workload to ensure compliance with regulatory submissions and internal timelines
- Perform investigation of deviations and monitoring of Corrective Actions/Preventive Actions (CAPAs) relating to non-compliance issues and findings, as well as assess the effectiveness of the CAPAs
- Oversee open and answered safety queries in the EDC and timely resolution of safety queries
- Review and provide input on Safety Operational Management Plan on behalf of Safety Operations
- Perform User Acceptance Test (UAT) on Safety Related Forms in EDC, ensuring correct dynamics and edit checks
- Provide comments on the e-Safety Reporting Form Specifications document and perform UAT
- Generate aggregate and ad-hoc reports for responsible products
- Oversee other activities related safety operations including ICSR submission or distribution to ECs/IRBs/Investigators/Business Partners
- Drug Safety professional with minimum 5 years of experience within drug safety and PV inclusive of case quality control and regulatory submissions of ICSRs worldwide
- Good knowledge of ICH E2B(R2) and (R3) specifications and entry guidance
- Ability to interpret health and medical records such as adverse event reporting forms, a discharge summary, etc
- Good knowledge of pharmacovigilance reporting rules and timelines
- Experience with clinical and post-marketing case processing, including MedDRA and WHO DD coding and narrative writing
- Experience with safety database; Argus is a plus but not mandatory
- Experience with EDC for clinical trial data collection
- Analytic and strategic thinking
- Excellent in detailed-oriented tasks
Genmab is a biotechnology company that leverages the effectiveness of an agile working environment to connect employees and innovate. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories.
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