Drug Safety Manager

Drug Safety Manager, Risk Management (RM)

Location:

Chicago, IL

We are supporting an innovative and growing biotech based in Chicago focused on advancing therapies in autoimmune disease, with a key indication in diabetes.

As they continue to expand their clinical development activities, they are looking to appoint a Drug Safety Manager, Risk Management (RM) to strengthen their pharmacovigilance function.

This is a highly cross‑functional role suited to someone who combines strong scientific judgment with structured thinking and the ability to bring teams together around safety strategy.

As Drug Safety Manager, RM, you will play a key role in the development and execution of risk management activities across clinical programs. You’ll contribute to safety signal evaluation, benefit‑risk assessments, and ongoing safety strategy, helping determine whether emerging data is related to the drug, the underlying disease, or a combination of both.

You will work closely with Clinical Development, Regulatory Affairs, Medical Affairs, Epidemiology, and external partners to ensure robust and compliant pharmacovigilance processes.

• Contribute to the development and maintenance of Risk Management Plans (RMPs)
• Support safety signal detection, evaluation, and documentation
• Lead or support benefit‑risk assessments
• Partner cross‑functionally to align on safety strategy and decision‑making
• Provide input into regulatory safety submissions and responses
• Apply epidemiological insight to contextualize safety findings
• Support inspection readiness and PV compliance activities

• Nursing background or Pharm
  
  D required
• ~5 years’ experience in Drug Safety / Pharmacovigilance
• Experience with Risk Management activities preferred
• Strong analytical mindset, able to critically assess whether safety findings relate to drug, disease, or both
• Exposure to epidemiology is highly desirable
• Excellent organizational skills and attention to detail
• Strong cross‑functional collaborator who can align stakeholders
• Chicago‑based or able to work locally preferred

• Opportunity to join a growing biotech in a high‑need autoimmune/diabetes space
• High visibility role with meaningful impact on patient safety
• Collaborative environment where your scientific judgment will directly influence development strategy

If interested, please apply below directly. Feel free to contact me directly on the below details if you have further questions:

J