Sr. Manager, Safety Operations / Case Management

Contract Manager / Sr. Manager MSRM Operations / Case Management

Beacon Hill was founded to set a new standard in search, career placement and flexible staffing. 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 are collected, managed and reported according to global SOPs and adverse event regulations. 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.
• Ensure training and enforce written procedures related to the collection requirements, processing and reporting of events from clinical trials and marketed sources.
• 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.
• 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.
• 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 :

Beacon Hill is an equal opportunity employer and individuals with disabilities and / or protected veterans are encouraged to apply. California residents : Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Company Profile : Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement. Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties / disciplines and industries. Learn more about Beacon Hill and our specialty divisions by visiting www.bhsg.com.

Benefits Information : Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings.