Associate Director, Global Patient Safety; GPS) Individual Case Safety Report; ICSR) Therapeutic Area; TA) Lead

Job Description General

Summary:

The Associate Director, Global Patient Safety (GPS) Individual Case Safety Report (ICSR) Therapeutic Area (TA) Lead is responsible for the oversight of global ICSR processing excellence and external business management within a specified TA. This position plans, executes and manages the technical aspects of Individual Case Safety Report (ICSR) processing and reporting, as well as provides oversight to external PV partners and vendors.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLSThe Associate Director, Global Patient Safety ICSR TA Lead plays a key role in managing global ICSR processing excellence and external business management. This position serves as subject matter expert in global pharmacovigilance regulations pertaining to ICSR processing, reporting, and submission. This position is a key contributor to developing and implementing best standards and practices in Global Patient Safety (GPS).

This position represents GPS in various cross-functional initiatives and therefore, must possess the relevant technical PV experience as well as good communication skills. The Associate Director, GPS ICSR TA Lead manages external PV business partners and vendors, and therefore must have excellent project management skills and relevant vendor management experience. Additionally, this position will support all GPS key operational goals and objectives.

Key

Duties and Responsibilities:

Leads (line or matrix) TA ICSR operations

Collaborates with other GPS TA Leads to ensure ICSR process adherence to global regulations, reinforce process harmonization across TAs as appropriate, provide vendor oversight through Key Performance Indicator (KPI) development and monitoring within the quality management system

Contributes to the ongoing development of innovative best practices for ICSR related processes including automation and artificial intelligence implementation

Mentors staff on managing all aspects of PV (pre and post-marketing), including working with relevant stakeholders to ensure GPS requirements are appropriately addressed, ongoing project maintenance, production of on-time, high quality cases

Guides staff on technical aspects of clinical trials and spontaneous case processing and reporting

Subject matter expert for audits, inspections, and health authority inquiries including verbal or written responses to auditors, inspectors, and health authorities

Represents directly or empowers team members to lead or support GPS in cross-functional initiatives and meetings

Promotes and demonstrates a culture of high performance and accountability within ICSR by leading by example, providing performance feedback to direct reports as well as collaborators, and by amplifying the achievements of team members

Escalation of challenges and propose solutions

Engages and leads a highly motivated, efficient and effective team.

Collaborates with GPS Quality, Standards & Training in the identification and remediation of regulatory/compliance risks and quality improvements

Performs case processing activities as needed

Knowledge and

Skills:

3-5 years of direct external partner and vendor/outsourcing management experience required

Hands-on e xperience with all operational aspects of ICSR processing and reportingL ine management experience preferred

Excellent project management skills with the ability to align internal and external resources

Possess a strong sense of responsibility, ability to work autonomously, and be a strong team player

Ability to manage and react constructively in a high-energy and fast paced environment

Excellent interpersonal and communication skills including verbal/written and presentation skills

Ability to evaluate and analyze procedural gaps

Education and Experience:

B.S. (or…