Global Pharmacovigilance 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

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.