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Contract Role-Manager Drug Safety
Company | Jobot |
Address | Fort Lauderdale, FL, United States |
Employment type | FULL_TIME |
Salary | |
Category | Nanotechnology Research,Research Services,Biotechnology Research |
Expires | 2023-05-23 |
Posted at | 1 year ago |
Want to learn more about this role and Jobot? Click our Jobot logo and follow our LinkedIn page!
Why join us?
Why join us?
- Reconciliation activities with all data sources providing safety information - Business Partners (BMS), IIST/Cooperative Groups (CCTG) and Internal Stakeholders to ensure compliance
- Act as record management coordinator for the Drug Safety Team
- Ensure all safety-related activities are conducted in accordance with company policies and procedures
- Manage the process for identifying, evaluating, selecting and managing outsourcing vendors involved in safety data activities including CROs, call centers, safety database vendors.
- Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timelines and timelines set by regulatory authorities. Follow up queries and clarifications with partners (CRO, IIST, Partners)
- Assist in the production and validation of appropriate safety data output from the safety database for required safety deliverables including generation of IB and DSUR.
- Manage CRO relationships and ensure timely delivery of safety data
- Review and reconcile activities associated with Pharmacovigilance Agreements and eventually start helping us develop our own internal SOP’s. Assist in the negotiation of safety exchange agreements with license partners in support of process definition, monitoring and other roles ensuring operational timelines can be met
- Oversee drug safety operations, including case processing, signal detection, and aggregate safety reports
- Accurately capture data of adverse event reports on the safety database in accordance with global and local regulatory requirements and ensure consistency between EDC data and Safety database
- Collaborate with cross-functional teams, including clinical operations and biostatistics, to ensure safety data is accurately reported
- Ability to work in a fast-paced environment and manage multiple projects simultaneously
- 3+ years of experience in drug safety and pharmacovigilance
- Knowledge of case processing and aggregate safety reporting
- Experience in preparing and presenting safety reports to senior management and regulatory agencies.
- Experience in oncology and solid tumors preferred
- Experience with safety data management and signal detection
- Excellent communication and interpersonal skills
- Bachelor's degree in a scientific field; advanced degree preferred
- Strong attention to detail and ability to analyze complex data
- Familiarity with safety databases, such as Argus
- Strong understanding of regulatory requirements, including FDA guidelines and REMs/RMPs
- Experience in project management and clinical operations
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