Mgr, PV Case Mgmt (GK)

Date Posted: 3/21/2023 9:41:51 AM

Manager, Pharmacovigilance Case Management
Bridgewater, NJ (hybrid)

The Manager of PV Case Management will work within the PV Operations team and oversee quality assessments of ICSRs (Individual Case Safety Reports).

Responsibilities:
Ensure quality of CAPAs within CHC cases on global studies. Oversee and document submission timeline issues to resolution. Develop and implement metric reports and presentations. Work cross-functionally with operations and regulatory groups to optimize PV submissions and quality.

Requirements:
PharmD or HCP with 6+ years’ experience in PV case activities. Experience in submission related activities and working with regulatory bodies. Strong cross-functional and communication skills. Ability to manage teams in case management and quality.

Please contact Greg Kane at gkane@clarkdavis.com