Rhythm Pharmaceuticals Senior Manager, Pharmacovigilance (PV) in Boston, Massachusetts
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with rare genetic disorders of obesity. 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.
As Rhythm expands its mission to treat patients with rare monogenic and syndromic forms of obesity, the Senior Manager, PV will be a key driver of the Company’s commitment towards Pharmacovigilance. Reporting directly to the Medical Director within Clinical Development, the ideal candidate will be responsible for setting the direction for the execution of PV activities related to setmelanotide both at the development and post-marketing stage, such as management of individual and aggregate safety reports, reconciliation and follow-up, preparation of PBRERs and DSURs, support to management and negotiation of global/regional PV commitments and RMPs, including potential post-marketing safety studies, and contribute to safety aspects of Regulatory interactions and filing.
The ideal candidate is able to perform several of these tasks with minimal supervision, has strong prioritization skills and is able to deploy strategic thinking to the evaluation of both individual cases and aggregated data in a timely fashion.
Rhythm values the face-to-face interactions we have while in the office and currently operates in a hybrid work model for Boston-based roles.
Responsibilities and Duties
Oversight of day-to-day adverse events case management including case intake, tracking and follow-up in accordance with PV procedures, regulations and timelines that are currently supported by Rhythm PV vendors
Contribute to preparation of key Global PV documents, including but not limited to PBRERs, DSURs and RMPs
Responsible for execution of Global PV processes and activities in collaboration with internal relevant functional areas and external parties as assigned, including PV vendor oversight
Support to clinical trial aspects related to patient safety, including interactions with Health Authorities and support to clinical submission activities as suitable for the candidate experience
Qualifications and Skills
Master’s degree within Medicine, Pharmacy, Nursing, Epidemiology, Biomedical sciences or equivalent healthcare degree
Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, Minimum of 3 years experience in PV in a global setting preferred
Experience in case management, follow-up and interaction with clinical trial site and prescribing physicians in accordance with Regulatory timelines
Experience in contributing to and reviewing aggregate safety reports (safety surveillance activities, PBRERs, DSURs, etc.)
Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information
Experience in signal detection, evaluation and management
Proficiency in English both written and spoken and excellent written and verbal communication skills with the ability to interact across multiple functions
Working knowledge of global PV Regulations
A solid understanding of diagnostic processes, diagnostic techniques and interpretation of diagnostic results
Ability to evaluate impact and consequences of diseases and medical interventions and to assess causality of adverse events
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 will involve travel, per pandemic travel guidelines.
More about Rhythm
Rhythm is a global, commercial-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity. The company is targeting the melanocortin-4 receptor (MC4R) pathway that is impaired due to genetic variants. This is a key biological pathway that regulates weight and hunger. A central element of Rhythm’s mission is to improve the understanding of these disorders and develop management strategies for patients who have no treatment options available to them. Rhythm was founded in 2008 and is based in Boston, MA. The company’s clinical development program is currently focused on several rare genetic disorders of obesity, all driven by genetic variants in the MC4R pathway. For healthcare professionals, visit www.RareObesity.com for more information. For those who may be affected or would like to learn more, visit www.LEADforRareObesity.com for more information.
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