Bachelor's degree in nursing, pharmacy, life sciences, or related field; advanced degree preferred.
3-4 years of experience in drug safety/pharmacovigilance, ideally in pharma/biotech.
Experience with adverse event case processing in a regulated environment.
Understanding of key pharmacovigilance concepts like seriousness and causality.
Familiarity with safety databases like Oracle Argus Safety.
Knowledge of FDA, ICH, and EU pharmacovigilance regulations.
Strong organizational skills and ability to manage multiple priorities.
Responsibilities
Support oversight and review of global safety vendor activities.
Manage intake, triage, and processing of Individual Case Safety Reports (ICSRs).
Monitor regulatory reporting timelines for expedited safety reports.
Perform quality reviews of safety cases for completeness and accuracy.
Conduct safety data reconciliation from various sources.
Assist in preparation and review of aggregate safety reports like DSURs and PSURs.
Collaborate with cross-functional teams in pharmacovigilance activities.
Benefits
Hybrid work model with flexibility in office attendance.
Potential for discretionary annual bonuses based on performance.
Eligibility for restricted stock units as part of compensation.
Opportunities for professional development and training.
Full Job Description
Opportunity Overview As a PV Specialist, you will support the ongoing development and operations of the pharmacovigilance function. You will support 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. This position will report to the Director of Pharmacovigilance.
Responsibilities and Duties
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 review of safety cases, including SAEs and SUSARs, to ensure completeness, accuracy, and appropriate case narratives.
Perform safety data reconciliation activities to ensure complete and accurate capture of adverse event data from clinical trials, product quality/complaints, business partners, and affiliates.
Support preparation and review of aggregate safety reports, such as Development Safety Update Reports (DSURs) and Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs).
Actively 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 the development, improvement and standardization of PV processes and methods.
Support inspection-readiness activities, including document collection, record maintenance, and evidence preparation.
Performs other PV activities as required.
Qualifications and Skills
Bachelor's degree in nursing, pharmacy, life sciences, or other related discipline required. Advanced healthcare or scientific degree a plus.
3-4 years of experience in drug safety/pharmacovigilance, preferably within the pharmaceutical/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 with the ability to manage multiple priorities and reporting timelines.
Excellent verbal and written communication skills, strong attention to detail, and demonstrated ability to collaboratively work across functions.
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $72,000 - $108,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
About Rhythm Pharmaceuticals, Inc.
Rhythm Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapies for the treatment of rare genetic disorders of obesity. The company's lead product candidate, setmelanotide, is a melanocortin-4 receptor (MC4R) agonist in development for the treatment of several rare genetic disorders of obesity, including POMC deficiency obesity, LEPR deficiency obesity, and Bardet-Biedl syndrome. Rhythm Pharmaceuticals is headquartered in Boston, Massachusetts.
