Sr. Manager, PV Ops

Manager/Sr. Manager PV Operations

Role Overview

The Manager/Sr. Manager PV Operations role will facilitate the ICSR customer review workflow, and keep oversight of ICSR queries. The role will support the Director, PV Operations through safety vendor interaction, and preparing for post-marketing PV task implementation.

Key Responsibilities

• Acting as unblinded Safety Operations role

• Managing the internal Safety Mailbox and ensuring unblinded mails are not shared to blinded individuals

• Support for ICSR submissions

• Ensuring appropriate regions are covered

• Being unblinded to maintain added QC of vendor submissions

• Investigating and helping to resolve late submission deviations

• Routing documents for internal review

• Sending feedback to vendor

• Final review

• Ensuring KPIs are captured appropriately and shared to stakeholders

• SMP updates

• Query tracking and resolution for SAE

• Maintaining standard query list

• Escalating query backlogs

• Supporting cross functional collaboration as needed to ensure compliant reconciliation

Qualifications

• Bachelor's degree in a life sciences or healthcare field (RN, PharmD, or equivalent) is required.

• 5-8 years of experience in pharmacovigilance or drug safety, with at least 3 years specifically in PV Operations within a clinical trial or post-marketing setting.

• Proven experience in an unblinded safety role, including the management of unblinded workflows, and maintaining the integrity of blinded study data.

• Demonstrated experience managing ICSR workflows, including vendor interaction, quality control (QC) of case narratives, and submission compliance.

• Familiarity with global pharmacovigilance regulations and safety reporting standards for both clinical and post-marketing.

• Direct experience with safety databases (e.g., Argus, ArisG) and a strong understanding of MedDRA and WHODrug coding.

Preferred Qualifications

• Experience in autoimmune or inflammatory diseases.

• Experience managing Safety Management Plans (SMPs) and participating in User Acceptance Testing (UAT) for safety system configurations or upgrades.

Experience working in a fast-paced, highly hands-on environment.