Job Information
Rhythm Pharmaceuticals Pharmacovigilance Specialist in Boston, Massachusetts
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. 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 have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of patients who receive our medications. You will be accountable for the day-to-day operational activities and support the activities of Rhythm’s safety vendor. This newly created position will report to the Associate Director of Pharmacovigilance.
Responsibilities and Duties
Reviews adverse event information received for completeness and consistency, triage of cases and initiates case follow-up activities with internal medical team, other cross-functional team members, and safety vendor, as applicable.
Provides support for oversight and review of vendor activities, including case processing , and aggregate reports. This may include the support of monitoring compliance, effective communication, and implementation of corrective and preventive actions, as needed.
Performs quality review of SAEs and SUSARs from clinical trials and post-marketing and ensures pertinent data has been included in the case narratives.
Assists cross-functional teams with PV and safety activities to ensure and promote compliance with pharmacovigilance standards and operational consistency across programs.
Assists in reconciliation activities to ensure reporting of all adverse event data.
Actively participates in cross functional projects that develop and support strong cross-functional relationships and communication.
Maintains knowledge of adverse event reporting process and safety system and contributes to the development, improvement and standardization of new processes and methods.
As an individual contributor, may serve as project lead for PV projects.
Undertakes activities necessary to be inspection ready.
Supports safety signal detection activities including support of medical safety and safety management teams, as needed.
May serve as delegate for AD as indicated.
Performs other activities as required.
Qualifications and Skills
Bachelor’s degree in nursing, pharmacy, or other life sciences required. Master’s degree, preferred. Non-medical credentials will be considered if PV experience can be demonstrated.
1-2 years of Drug Safety and Pharmacovigilance experience.
Knowledge of FDA, ICH, EU Regulations and Requirements for Pharmacovigilance required.
Solid understanding of the cross-functional drug development processes (Regulatory, Clinical Operations, Data Management, and Biostatistics).
Demonstrable organizational and workflow prioritization capabilities
Excellent verbal and written communication skills, detail-oriented personality, and ability to collaboratively work across functions.
Ability to make initial clinical judgement and seek medical oversight on a wide area of topics, both to internal and external stakeholders
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.
More about Rhythm
Our lead asset, IMCIVREE® (setmelanotide), is a precision medicine designed to treat hyperphagia, an insatiable, pathological hunger characterized by abnormal food-seeking behaviors, and early- or rapid-onset severe obesity caused by an impairment of a pathway in the hypothalamus called the melanocortin-4 receptor (MC4R) pathway. IMCIVREE® is the first and only approved therapy for certain rare MC4R pathway diseases in the United States, Europe, Great Britain and several other countries. In collaboration with leading experts across the world, Rhythm is advancing the most comprehensive clinical research program ever initiated in MC4R pathway diseases, including a Phase 3 trial for acquired hypothalamic obesity. In addition, we are leveraging our extensive genetic database, global network of researchers, a track record of regulatory successes and global commercial infrastructure to develop a full portfolio of treatment options to patients struggling with hyperphagia and severe obesity and ensuring they get the treatment that is right for them.
We continue to advance care and precision medicines that address rare diseases. We are focused on expanding access to IMCIVREE® to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.
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