Job Description

Senior Manager, Global Patient Safety Operations

W2 Contract-to-Hire

Salary Range: $145,600 - $166,400 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

This position will be responsible for the management, development, and oversight of Global Patient Safety operational activities in the execution of safety information collection and reporting for the assigned clinical programs.

Duties and 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 the 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).

Requirements and Qualifications:

• 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 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 Qualifications:

• 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

Desired Skills and Experience

Global Patient Safety Operations, Pharmacovigilance, Safety Reporting, Regulatory Compliance, Clinical Trials, CRO Management, Vendor Management, Cross-functional Collaboration, Safety Database Management, Regulatory Authorities Reporting, IRB/Ethics Committee Reporting, Clinical Trial Protocols, Informed Consent Forms, Investigator Brochure, Reference Safety Information, Aggregate Reports, Safety Data Exchange Agreements, Pharmacovigilance Agreements, SAE Reconciliation, SAE Query Resolution, Team Management, Problem Solving, Multitasking, Prioritization, Data Analysis, Conceptual Thinking, Persuasion, Relationship Management, Interpersonal Skills, Confidentiality Management, Investigator-Sponsored Trials, Extended Use Programs, Business Partnerships

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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