Sr.Manager, PV Operations Job

Sr.Manager, PV Operations is needed to perform the following duties:

· Manage PV vendor activities, including ICSR processing, submissions, safety database configurations, etc. and provide necessary guidance and expertise to ensure quality and compliance of the deliverables, monitor and maintain quality metrics for feedback and improvement.

· Perform quality review of vendor processed cases to verify accuracy and consistency against relevant source documents, and compliance with process requirements

· Support and guide CRO with safety related query processes, coding reviews, safety data reconciliations, and other related PV data cleaning activities to enable delivery of quality data throughout the company product lifecycle.

· Participate in the development and implementation of PV processes and SOPs to ensure that all PV operations, including ICSR processing and submissions, comply with global regulations and industry standards

· Support inspection readiness activities and participate in internal audit or HA inspections by ensuring quality and accuracy of the PV documents.

· Participate in clinical team support including protocol review, AE reporting training, clinical study report review, patient narrative preparation, etc. as necessary

· Represent PV department at meetings where issues relevant to PV operations may be discussed, and when cross functional collaboration is needed to ensure alignment on procedures and shared deliverables

· Maintain awareness of any updates in the global regulations related to PV, company product knowledge, corporate SOPs and policies, and industry standards, and ensure consistency in application to PV activities.

Bachelor's Degree is required in Life Science or Pharmaceutical Science or Pharmacy.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave