Hybrid Pharmacovigilance Specialist—Drug Safety

Rhythm Pharmaceuticals, Inc; Boston (MA); Hybrid; USD 72,000 - 108,000; Full time

Benefits offered by this job

Discretionary annual bonus

Hybrid work model

Competitive benefits package

Job summary

Rhythm Pharmaceuticals, Inc. in Boston, MA, is seeking a PV Specialist to support pharmacovigilance for clinical development and marketed products. The role reports to the Director of Pharmacovigilance and focuses on case management, safety reporting, and vendor oversight.

You will work across Clinical Operations, Regulatory Affairs, Data Management, and Quality to ensure compliant handling of safety data and timely submissions. A hybrid Boston-office role with possible travel is required.

Qualifications

• 3–4 years of experience in drug safety/pharmacovigilance in pharma/biotechnology.
• Experience with adverse event case processing and medical/safety review processes in a regulated environment.
• Understanding of seriousness, expectedness, causality, listedness, and regulatory reportability concepts.
• Familiarity with FDA, ICH, and EU pharmacovigilance regulations and requirements.
• Working knowledge of drug development and cross-functional interfaces (Regulatory, Clinical Operations, Data Management, Biostatistics).
• Strong organizational skills and ability to manage multiple priorities and timelines.
• Excellent verbal and written communication skills and collaboration across functions.

Responsibilities

• Oversee global safety vendor activities, including case processing, reconciliation, and aggregate report management.
• Triage, process, follow-up, quality review, and reconciliation of IC S R s.
• Monitor regulatory reporting timelines and support expedited safety submissions.
• Perform quality review of safety cases (SAEs/SUSARs) and ensure complete narratives.
• Reconcile safety data from trials, quality issues, and partners; ensure data integrity.
• Prepare and review DSURs/PSURs/PBRERs; support safety reporting activities.
• Collaborate with Clinical Operations, Regulatory Affairs, Data Management, and Quality.
• Maintain up-to-date PV knowledge and contribute to process improvements.
• Support inspection-readiness through documentation and evidence preparation.
• Perform other PV activities as required.

Skills

Pharmacovigilance

Regulatory awareness

Cross-functional collaboration

Attention to detail

Strong communication

Education

Bachelor’s degree in nursing, pharmacy, life sciences

Advanced healthcare degree

Tools

Oracle Argus Safety

Safety databases

Job description

Rhythm Pharmaceuticals, Inc. in Boston, MA, is seeking a PV Specialist to support pharmacovigilance for clinical development and marketed products. The role reports to the Director of Pharmacovigilance and focuses on case management, safety reporting, and vendor oversight.

You will work across Clinical Operations, Regulatory Affairs, Data Management, and Quality to ensure compliant handling of safety data and timely submissions. A hybrid Boston-office role with possible travel is required.