The Manager of Clinical Safety Operations supports drug safety and pharmacovigilance operation activities for clinical trials. In this role, the individual will be primarily responsible for ensuring end to end safety reporting requirements and processes are established and maintained for clinical trials (phase 1-3). This position may be remote within the United States or hybrid on-site role in Redwood City, CA. In the role, the employee is expected to be onsite and travel (domestic and internationally) to support business needs as/when required, up to 20% of time.

Responsibilities:

• Support the oversight of drug safety service providers to ensure collection, processing, reporting and reconciliation of adverse events reports is compliant with global regulatory requirements and standard operating procedures (SOPs)
• Serve as a Safety Operations Lead on study management team(s)
• Create/revise and implement department SOPs, work instructions and Safety Management Plans (SMPs)
• Develop and deliver training for safety related topics for internal personnel and external vendors
• Perform in line and/or end of line quality review of adverse event reports
• Support process improvement initiatives and safety systems implementation/maintenance activities
• Ensure the clinical trial master file (TMF) is maintained in an inspection ready state for all safety-related documents
• Support and participate in audits and inspections, including preparation activities
• Assist with safety operations and/or safety science projects, as necessary

Preferred Skills, Qualifications and Technical Proficiencies:

• Knowledge of Argus (or similar safety applications), electronic data capture systems, and MedDRA and WHO Drug coding dictionaries
• Excellent communication and collaboration skills in a multidisciplinary team
• Ability to work independently and manage multiple projects in a dynamic, fast-paced environment to meet patient and corporate needs

Preferred Education and Experience:

• Bachelor’s degree in healthcare or life sciences degree such as RN or BSN, PharmD is required
• Minimum of 5 years Drug Safety/PV experience in a global environment
• Experience in both clinical required, and post marketing safety operations preferred
• Working knowledge of FDA, EU and ICH guidelines for safety reporting and processing for clinical trials and post marketing

The pay range that the Company reasonably expects to pay for this headquarters-based position is $144,800 - $212,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.