Sr. Manager, ICSR Quality

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Reporting to the Head of Risk Management, Aggregate Reports & Pharmacovigilance, as the Senior Manager, ICSR Quality, you will have Individual Case Safety Reports (ICSRs) accountability and oversee the operational management and activities performed by the Global Case Management Pharmacovigilance vendor(s) for CSL Behring, CSL Seqirus, CSL Vifor and CSL Plasma products.

This is a hybrid role, which offers a combination of an onsite and remote work schedule.

• Oversight of Global Case Management Pharmacovigilance vendor(s) as it relates to governance, financials, contracts, quality and training, and resourcing.
• Ensure consistency and monitor quality and compliance of end-to-end case processing and other outsourced activities performed by the case management vendor.
• Oversee case management vendor(s) to manage and resolve emerging issues.
• Develop and/or maintain/update existing documents for relevant vendor responsibilities.
• Contribute ICSR quality strategy.
• Responsible for Global ICSR Reconciliation activities.
• Support audit/inspections and contribute to CAPAs specific to case quality or vendor/resource management, as required.

• BS/BA, RN, Pharmacist, or equivalent.
• Minimum of 8 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience.
• Global pharmacovigilance database knowledge with proficient knowledge of global and local regulatory rules and regulations.
• Experience working with third parties (e.g., contract service providers) and relationship management.

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit

Location:

Philadelphia, PA | Salary: $–$ | Posted: 1 day ago