Senior Project Manager (Vigilance)

Fresenius Kabi•Lake Zurich, IL

13d•Onsite

About The Position

The Senior Project Manager is responsible for leading and managing new projects within the Local and Global Vigilance team and product partnering due diligence activities for the US Vigilance team. The Vigilance Senior Project Manager reports directly to the head of Vigilance (US) and works closely across all departments and areas within Global Vigilance and alliance management to ensure the project, product, and cross functional organization is aligned. The incumbent is expected to ensure the Vigilance project meets the strategic requirements of the department as well as ensure the Vigilance activities are consistent and compliant with regional and global strategies, procedures and regulations. This position requires working onsite in Lake Zurich, IL 3+ days per week. This position is not eligible for sponsorship either now or in the future.

Requirements

Bachelor’s degree required.
8+ years of experience in the pharmaceutical industry in a drug safety or pharmacovigilance department required.
3+ years of management experience or experience leading successful teams required.
Understand FDA compliance, quality, risk, mitigation and planning, and management.
Ability to understand and interpret federal regulations and company operating procedures as they apply to medically complex adverse drug events.
Knowledge of PC systems and Microsoft Office Suite required.

Nice To Haves

Medical/Clinical professional or advanced degree preferred (e.g., PharmD, RPh, RN, MS, or MBA).
3+ years of hospital/clinical experience preferred.
Global experience preferred.
Experience with adverse drug event software is preferred.
Knowledgeable of the ARIS global database is a plus.

Responsibilities

Lead and manage new initiatives whether initiated by a global function, or a local business contract, establishing project timelines and key goals, ensuring Vigilance participation on global and local due diligence evaluations.
Responsible for writing and/or review of applicable Standard Operating Procedures (SOPs).
Identify new procedures needed and changes to be made to established procedures to implement projects.
Ensure that all global and local procedures are in alignment.
Responsible for leading and managing all activities related to pharmacovigilance activities with Fresenius Kabi USA business partners, and third-party manufacturers (TPM), both locally and globally.
Manage communications with product business partners and establish pharmacovigilance and data exchange agreements.
Establish relationships and safety and data exchange agreements (SDEA) with business partners or TPMs, ensuring they meet all global and local regulations, policies and procedures.
Ensure execution and implementation of SDEA and provide oversight of all data exchange and reconciliation activities.
Drive new initiatives, establishing project timelines and key goals, ensuring Vigilance participation on global and local due diligence evaluations.
Lead a team of Drug Safety Scientists and Data Specialists in all aspects of adverse drug event processing and reporting, reconciliation activities, and other tasks/responsibilities as required.
Review and approve adverse event information entered into global complaint management workflow (gCMW).
Train and mentor staff regarding all established procedures and agreements.
Responsible for managing and facilitating the preparation, review, and submission of expedited, as well as non-expedited case reports in accordance with SOPs, as well as domestic and foreign regulatory requirements.
Serve as an Adverse Drug Event (ADE), PV expert, and MedDRA coding expert.