Risk Management Lead

Job Description

Position Title: Global Safety Risk Management Lead

Location: Chicago, Illinois

Our client is a prominent global healthcare organization dedicated to improving patient outcomes through innovative medical solutions. We are currently seeking a specialized professional to join their safety team as a Pharmacovigilance Risk Management Specialist. In this role, you will be instrumental in developing strategies that ensure the safe and effective use of life sustaining medical products on a global scale.

Core Responsibilities

You will serve as the primary author for Pharmacovigilance Risk Management Plans, utilizing various regional and international templates to ensure full regulatory compliance. You will lead the cross functional review and approval process for these documents and act as a key point of contact for health authority inquiries and commitments.

Your work will involve managing project timelines for critical submissions and representing the risk management department in strategic safety discussions. You will also collaborate with international affiliates to implement risk minimization measures and provide mentorship to junior team members to ensure consistency and quality across the department.

Required Qualifications

A Bachelor degree in Nursing, Biological Sciences, or a related clinical or medical field is required.

Minimum of two years of professional experience within the pharmaceutical industry, specifically in Pharmacovigilance, Clinical Research, or Medical Affairs.

Proven experience of two to three years specifically focused on authoring Pharmacovigilance Risk Management Plans.

Direct experience with European Union RMP requirements and the authoring of EU RMPs is essential.

Strong understanding of global regulatory landscapes and submission processes.

Exceptional technical writing abilities and the skill to translate complex clinical data into clear regulatory documentation.

Excellent project management skills and the ability to work effectively with diverse cross functional teams.

Preferred Skills

An advanced degree or direct clinical practice experience.

Experience handling non EU risk management plans or generic EU submissions.

Familiarity with the implementation of active risk minimization activities.

Compensation and Benefits

The anticipated base salary for this position ranges from 112,000 to 154,000 USD per year, depending on the candidates specific experience, skills, and location.

A 5,000 USD sign on bonus is being offered for this role, payable after the initial thirty days of employment.

Our client provides a comprehensive benefits package including immediate medical and dental coverage, a 401k plan with company matching, an employee stock purchase program, and generous paid time off.

Applicants must be currently authorized to work in the United States for any employer, as visa sponsorship is not available for this position.

This is an equal opportunity employer committed to diversity and workplace inclusion. All qualified applicants will receive consideration for employment without regard to protected characteristics.