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Position Summary:
The Contract Manager/Sr. Manager MSRM Operations/Case Management oversees the execution of deliverables associated with case processing, expedited reporting and submission of designated aggregate safety reports. This position ensures individual reports from all sources (spontaneous, literature, product/patient support programs, market research programs, clinical trials (pre-& post approval), medical information, call centers, commercial affiliates, partner companies, health authorities, post marketing commitment studies, etc.) are collected, managed and reported according to global SOPs and global adverse event regulations and guidelines.
This position oversees case processing activities, processes, procedures, and interdepartmental projects involving safety data processed by a vendor and captured in the global safety database. This position collaborates within MSRM and with other company functional areas and cross-functional teams, and interacts with CROs, vendors, partners, and study teams on all aspects of safety data collection and reporting.
Key Responsibilities:
- Organize, direct and manage technical and human resources to efficiently support the capture and management of individual safety reports in accordance with global safety regulations in a scalable approach
- Ensure training, and enforce written procedures related to the collection requirements, processing and reporting of events from clinical trials and marketed sources to ensure proactive surveillance of products
- Contribute to safety database upgrades and configuration changes; perform user acceptance testing
- Provide input and guidance to submissions and case processing vendor teams; facilitate training and develop training materials for vendor training
- Contribute to signaling and aggregate reporting activities through ensuring quality and accuracy of individual cases through collaboration with Safety Sciences
- Participate as Safety Operations subject matter expert on Clinical Trial teams
- Collaborate internally and with vendors to establish and monitor key performance indicators (KPIs) that are relevant and in alignment with regulations/industry standards
- Provide subject matter expertise and collaborate with MSRM Standards, Compliance and Training colleagues, Pharmacovigilance Quality Assurance colleagues and vendors to ensure compliance with world-wide regulations for case quality and timely submissions
- Support MSRM and cross-functional compliance activities through the compilation and delivery of compliance metrics at required intervals/frequencies
- Represent the functional area in internal committees and with external parties (e.g. partners, regulatory agencies)
- Participate in audits and inspections
- Serve as a point of escalation for issue resolution
- Drive timely decisions and appropriately shift functional timelines, resources and priorities
- Collaborate with relevant departments to determine budget and resources within area of responsibility
Requirements:
- Health care professional (e.g. RN, pharmacist) or other life sciences BS/BA, preferred
- Minimum of 5+ years of relevant drug safety/pharmacovigilance experience
- Knowledge of current industry standards and benchmarks
- Demonstrated ability to oversee and manage vendors
- Extensive knowledge and experience with MedDRA and WhoDD coding dictionaries
- Experience with software-based drug safety systems (ARGUS, ARISg, or equivalent)
- Excellent computer skills (MS Office)
- Advanced knowledge of US and EU pharmacovigilance regulations for development and marketed products
- Strong planning and organizational skills
- Strong orientation to teamwork
- Excellent written/verbal communication and interpersonal skills
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