Bayside Solutions ยท 15 hours ago
Senior Manager, Global Patient Safety Ops
United States
Contract
Remote
Senior Level
$177K/yr - $198K/yr
5+ years expBayside Solutions is a company that specializes in healthcare solutions, and they are seeking a Senior Manager for Global Patient Safety Operations. This role is responsible for overseeing safety information collection and reporting for clinical programs, ensuring compliance with global regulatory requirements, and managing cross-functional collaboration.
Information TechnologyStaffing AgencyTelecommunicationsVirtual Reality
No H1B
Responsibilities
Participates in the development of Global Patient Safety Operations operational objectives, policies, and procedures
Represent Global Patient Safety in different cross-functional team meetings
Collaborate with other functional groups to achieve clinical program goals
Oversee Pharmacovigilance Contract Research Organization (PV CRO) in the execution of safety reporting in clinical studies
Manage PV CROs to ensure compliance with required timelines, that potential issues are being communicated, and that resolution is achieved in a timely manner
Oversee reporting of safety reports to global regulatory authorities, central IRB/ethics committees, and investigators to ensure compliance with global regulatory requirements
Ensure timely and accurate setup of global safety reporting and safety database in assigned clinical programs
Support authoring and updates of clinical trial protocols, informed consent forms, Investigator Brochure (including the Reference Safety Information section), and aggregate reports
Support the execution and maintenance of Safety Data Exchange Agreements /Pharmacovigilance Agreements with business partners
Collaborate with other functional groups in SAE reconciliation and SAE query resolution activities
Support the Global Patient Safety team in other PV activities appropriate to experience and expertise
May oversee or be responsible for one or more junior team member(s)
Qualification
Required
Bachelor's Degree in a healthcare field
Minimum of 5 years of relevant experience in pharmacovigilance operational activities
Hands-on experience working with CROs/vendors and management of external resources
Strong background in safety reporting, regulatory compliance, and global safety reporting/regulations in clinical trials
Able to problem solve, focus on details, multitask, prioritize options, work independently, anticipate challenges, and execute assigned deliverables
Ability to analyze situations and data that require conceptual thinking and in-depth knowledge of organizational objectives
Ability to persuade others in sensitive/complex situations while maintaining relationships
An innovative team player with the capacity to be effective in a dynamic, continuously improving, and fast-paced company environment
Excellent interpersonal skills, including the ability to work in cross-functional team environments and with external vendors
Exercise discretion regarding highly confidential internal and external communications
Preferred
Master's Degree or higher in a healthcare field
7+ years of relevant experience in pharmacovigilance operational activities
Experience working with investigator-sponsored trials, extended use programs, and business partnerships
Company
Bayside Solutions
Bayside Solutions is a staffing and recruiting company offering IT, telecom, and scientific staffing services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
B
Bob Klotz
Founder
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