Pharmacovigilance Specialist

Rhythm Pharmaceuticals • Boston, MA

1d • $72,000 - $108,000 • Hybrid

About The Position

The Pharmacovigilance Specialist supports the ongoing development and operations of Rhythm’s pharmacovigilance function. The role supports day-to-day pharmacovigilance activities for clinical development and marketed products, including case management, safety reporting, reconciliation, and oversight of activities performed by Rhythm’s global safety vendor. The position reports to the Director of Pharmacovigilance.

The role is based at Rhythm’s corporate office in Boston, Massachusetts, under a hybrid-work model. The successful candidate must be willing and able to work in the Boston office in coordination with departmental and business needs. Some travel may be involved.

Requirements

• Bachelor’s degree in nursing, pharmacy, life sciences, or another related discipline.
• 3–4 years of experience in drug safety or pharmacovigilance, preferably in the pharmaceutical or biotechnology industry.
• 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 safety databases such as Oracle Argus Safety or comparable systems.
• Knowledge of FDA, ICH, and EU pharmacovigilance regulations and requirements.
• Working knowledge of drug development and relevant cross-functional interfaces, including Regulatory, Clinical Operations, Data Management, and Biostatistics.
• Strong organizational skills and ability to manage multiple priorities and reporting timelines.
• Excellent verbal and written communication skills, strong attention to detail, and demonstrated ability to work collaboratively across functions.
• Willingness and ability to work in the Boston office in coordination with departmental and business needs.

Nice To Haves

• Advanced healthcare or scientific degree.
• Experience in the pharmaceutical or biotechnology industry.

Responsibilities

• Support oversight and review of global safety vendor activities, including case processing, safety data reconciliation, and aggregate report management.
• Support intake, triage, processing, follow-up, quality review, and reconciliation of Individual Case Safety Reports (ICSRs).
• Monitor regulatory reporting timelines and support timely submission of expedited safety reports.
• Perform quality reviews of safety cases, including SAEs and SUSARs, to ensure completeness, accuracy, and appropriate case narratives.
• Perform safety data reconciliation to ensure complete and accurate capture of adverse event data from clinical trials, product quality and complaints, business partners, and affiliates.
• Support preparation and review of aggregate safety reports, including Development Safety Update Reports (DSURs) and Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs).
• Participate in cross-functional pharmacovigilance activities and collaborate with Clinical Operations, Regulatory Affairs, Data Management, Quality, and other relevant functions.
• Maintain knowledge of adverse event reporting requirements, pharmacovigilance processes, and safety systems, and contribute to developing, improving, and standardizing PV processes and methods.
• Support inspection-readiness activities, including document collection, record maintenance, and evidence preparation.
• Perform other pharmacovigilance activities as required.

Benefits

• The role may be eligible for benefits and other compensation, such as restricted stock units.
• A discretionary annual bonus may be available based on individual and company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level