Senior Pharmacovigilance Manager — Remote

Pulmovant; Northern (KY); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Pulmovant seeks a Senior Manager, Pharmacovigilance to lead safety surveillance across our respiratory portfolio. You will oversee SAE case processing, global regulatory reporting, and vendor management, ensuring ICH-GCP and GVP compliance while partnering with clinical, regulatory, and medical teams.

The ideal candidate brings 7+ years in pharmacovigilance, hands-on Argus Safety experience, and a track record in DSURs and risk management.

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or related field required; advanced degree preferred.
• Minimum of 7+ years of pharmacovigilance/drug safety experience in biotech/pharma.
• Experience with DSURs, PSURs/PBRERs, and risk management plans desirable.

Responsibilities

• Oversee end-to-end case management for SAEs and regulatory reporting.
• Maintain PV vendor and CRO relationships, including safety databases.
• Author/review PV SOPs and safety documentation (DSURs, study reports).
• Support signal detection, safety data reviews, and risk management activities.
• Ensure compliance with ICH-GCP, FDA, EMA, and GVP guidance.

Skills

Pharmacovigilance

PV operations

Safety reporting

Regulatory affairs

Education

Bachelor's degree in life sciences

Tools

Oracle Argus Safety

Job description

Pulmovant seeks a Senior Manager, Pharmacovigilance to lead safety surveillance across our respiratory portfolio. You will oversee SAE case processing, global regulatory reporting, and vendor management, ensuring ICH-GCP and GVP compliance while partnering with clinical, regulatory, and medical teams.

The ideal candidate brings 7+ years in pharmacovigilance, hands-on Argus Safety experience, and a track record in DSURs and risk management.