Risk Management Lead

Sotalent; Chicago (IL); On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Medical and dental coverage

401k with company match

Employee stock purchase program

Generous paid time off

Job summary

Global Safety Risk Management Lead with Sotalent seeks a pharmacovigilance specialist to author risk management plans and drive regulatory-compliant submissions. You will coordinate cross-functional reviews and serve as a key contact for health authority inquiries to advance global safety programs.

The role requires a nursing or biological sciences background and 2+ years in pharmacovigilance with EU RMP experience, strong regulatory writing, and proven project leadership.

Qualifications

• Bachelor degree in Nursing, Biological Sciences, or related field.
• Minimum of two years in pharmacovigilance, Clinical Research, or Medical Affairs.
• Two to three years authoring Pharmacovigilance Risk Management Plans.
• Direct EU RMP experience and EU RMP authoring is essential.
• Strong understanding of global regulatory landscapes and submission processes.
• Exceptional technical writing and ability to translate data into regulatory docs.
• Excellent project management and cross functional collaboration.

Responsibilities

• Author Pharmacovigilance Risk Management Plans using regional and international templates.
• Lead cross-functional review and approval for risk management documents.
• Coordinate health authority inquiries and strategic safety discussions.

Skills

Pharmacovigilance

EU RMPs

Regulatory writing

Project management

Cross-functional collaboration

Medical affairs

Education

Bachelor's degree in Nursing

Biological Sciences

Related clinical/medical field

Job description

Position Title: Global Safety Risk Management Lead

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.