Job Description
Job Description
Job Description
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 position will report to the 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 Director as indicated.
- Performs other PV 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 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 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
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. Powered by JazzHR
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