Hybrid Product Safety & Pharmacovigilance Manager

at Shionogi Inc. (U.S.)

• Job title: Product Safety & Pharmacovigilance Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $130,000 - $150,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Florham Park, United States

About the role

• Product Safety & Pharmacovigilance Manager overseeing drug safety and compliance in clinical trials. Managing CROs and ensuring adherence to regulatory requirements while leading a team in Florham Park, NJ.

Responsibilities

• Manage activities of CROs, vendors, and temporary staff performing PV operations.
• Oversee and guide case processing activities to ensure effective monitoring and evaluation of product safety information.
• Oversee PV system to ensure compliance of employees, partners and distributors.
• Maintain safety databases (e.g., Argus, ArisG) and ensure data accuracy and compliance.
• Ensure ongoing maintenance and revision of PSPV Standard Operating Procedures, Work Instructions, and Job Aids.
• Ensure PV operation continuity including maintenance of process or disaster recovery plan of Safety Database.
• Supervise and manage preparation and submission of aggregate reporting in accordance with applicable regulations.
• Maintain training matrix in PSPV team and lead trainings of PSPV members or new hires.
• Oversee preparation and execution of deviation reports, note to files and Corrective and Preventive Actions (CAPAs).
• Manage pharmacovigilance agreements or safety clause in contracts with partners or CROs.
• Act as the responsible contact person for safety-related aspects and PV.

Requirements

• Bachelor’s degree in pharmacy or nursing (BSN/RN) required.
• Minimum of 5 years in Drug Safety/Pharmacovigilance in the pharmaceutical industry.
• Previous experience with safety database programs; i.e., Argus, Aris-G, etc. desired.
• Applied knowledge of global regulations and global compliance timelines desired.
• Demonstrated computer experience with MS Word, Excel, Access and Outlook.
• Excellent written and verbal communication skills, organizational skills and attention to detail.
• Demonstrated ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team.
• Skilled at people management including overseeing and controlling outsourced vendor activities in a compliance/regulated field.
• Highly analytical with the ability to give attention to detail.
• Capable of troubleshooting and managing multiple projects simultaneously.

Benefits

• Health insurance
• Paid time off
• Professional development opportunities
• Flexible working arrangements