- Salary
- $72k – $108k
- Location
- Boston, MA
- Workplace
- Hybrid
- Type
- Full-time
- Seniority
- Mid
- Experience
- 3+ years
- Closing date
- Today
- Source
- ApplyToJob
Description
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
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
Qualifications and Skills
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.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
Inherent in our core values is the commitment to act ethically and with integrity in all we do.
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
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.
More about Rhythm
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.
At Rhythm our core values are:
- We are committed to advancing scientific understanding to improve patients’ lives
- We are inspired to tackle tough challenges and have the courage to ask bold questions
- We are eager to learn and adapt
- We believe collaboration and ownership are foundational for our success
- We value the unique contribution each individual brings to furthering our mission
Inherent in our core values is the commitment to act ethically and with integrity in all we do.
Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
Skills
OracleClinical TrialsFDA