Manager, Office of Safety Operations (Remote)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose:

This position supports the Safety Operations organization to achieve its mission of improving patient lives by delivering high quality, and timely adverse event management and through driving industry leading ICSR operations, ICSR standards and technology at AbbVie.

The Manager, Office of Safety Operations sits in the ICSR Compliance department within the Safety Operations function.

This position is responsible for monitoring and ensuring compliance with the global regulatory reporting of ICSRs. The role includes management of investigations to address compliance deviations and drive continuous improvement, as well as managing license partners to ensure alignment on reporting obligations and safety data exchange requirements.

The successful candidate will also support internal and external audits and regulatory inspections by leading in the front room, providing documentation, data analysis, and subject matter expertise related to ICSR processes,

Responsibilities:

• Designs and implements compliant and efficient ICSR pharmacovigilance processes, technologies & training
  Leads improvement of Abbvie’s global clinical and post-marketing case management processes, technology & training
  Implements new ICSR pharmacovigilance legislation into quality systems, metrics, technical requirements & training
• Leads effective cross-functional collaboration with an emphasis on building business relationships with relevant AbbVie stakeholders, including PPS, Commercial, GMA, RDQA, and Affiliates to establish and maintain harmonized ICSR processes
  Leads internal audits and external regulatory inspection activities; supports functional corrective and preventive action in