Senior Manager, Global Patient Safety Ops

Bayside Solutions; United States; Remote; USD 176,800 - 197,600; Full time

Job summary

A leading healthcare management firm is seeking a Senior Manager of Global Patient Safety Ops. This remote role involves overseeing Global Patient Safety operations, managing pharmacovigilance activities and collaborating with cross-functional teams. The ideal candidate will hold a Bachelor's degree in a healthcare field and have over 5 years of relevant experience. Strong regulatory compliance knowledge and team leadership skills are essential. The salary range is $176,800 - $197,600 per year.

Qualifications

• 5+ years of relevant experience in pharmacovigilance operational activities.
• Experience working with CROs and management of external resources.
• Strong background in safety reporting and regulatory compliance.

Responsibilities

• Manage Global Patient Safety operational activities.
• Oversee Pharmacovigilance CRO for safety reporting.
• Support authoring of clinical trial protocols and informed consent forms.

Skills

Global Patient Safety Operations

Pharmacovigilance Operations

Clinical Safety Management

Regulatory Compliance

Cross-Functional Collaboration

Attention to Detail

Problem Solving

Education

Bachelor's Degree in a healthcare field

Master's Degree or higher in a healthcare field

Job description

Senior Manager, Global Patient Safety Ops

W2 Contract

Salary Range: $176,800 - $197,600 per year

Location: Redwood City, CA - Remote 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 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 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 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 Operations, Clinical Safety Management, Global Safety Reporting, Safety Information Collection, Safety Case Processing, Regulatory Compliance, Global Regulatory Submissions, Safety Reporting to Health Authorities, IRB/Ethics Committee Reporting, Investigator Safety Reporting, CRO Oversight and Management, Vendor Management, External Resource Management, Pharmacovigilance Agreements, Safety Data Exchange Agreements, SAE Management, SAE Reconciliation, SAE Query Resolution, Safety Database Setup and Management, Clinical Trial Safety Oversight, Clinical Program Support, Cross-Functional Collaboration, Safety Governance, Safety Policies and Procedures, Risk Management, Aggregate Safety Reporting, Investigator Brochure Authoring, Reference Safety Information (RSI), Clinical Trial Protocol Support, Informed Consent Form Support, Investigator-Sponsored Trials, Extended Use Programs, Business Partner Safety Support, Compliance with Timelines, Issue Identification and Resolution, Data Analysis and Critical Thinking, Problem Solving, Attention to Detail, Multitasking and Prioritization, Independent Execution, Stakeholder Communication, Influencing and Negotiation, Confidential Information Handling, Team Leadership, Mentorship of Junior Staff

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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