Responsibilities and Duties- Responsible for supporting all PV operational activities across Rhythm products in clinical development and post approval stages ensuring the delivery of high-quality safety data.
- Oversee day-to-day individual case safety reports management from clinical trials and post-marketed sources in accordance with PV procedures, regulatory requirements and timelines that are supported by Rhythm PV vendors.
- Actively involved in PV vendor(s) management through daily emails, monitoring Key Performance Indicators (KPIs) and metrics, periodic governance meetings, and implementation of effective Corrective and Preventative Action plans, as applicable.
- Contribute to planning and preparation of key global PV documents, including but not limited to Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Safety Update Report (PSUR), Development Safety Update Reports (DSURs), and Risk management Plans (RMPs).
- Act as a PV Lead for the assigned clinical studies and support cross-functional teams' deliverables, as applicable.
- Provide input to clinical study documents, including protocols, Investigators Brochures, clinical study reports, regulatory documents/responses, and safety management plans.
- Actively participate in PV team strategic planning, process improvement, audits and PV work instructions and standard operating procedures development.
- Support, train, mentor Rhythm PV junior staff and/or Rhythm's vendors, as needed.
- Stay abreast of evolving PV regulatory landscape and industry best practices to ensure ongoing compliance and operational excellence.
Qualifications and Skills- Bachelor's degree in Medicine, Pharmacy, Nursing, Epidemiology, Biomedical Sciences, or equivalent healthcare degree.
- 8+ years of PV operations experience is required.
- 3+ years of PV operations experience in a global post-marketing setting preferred.
- Expert knowledge of global PV requirements, Good Pharmacovigilance Practices, ICH Guidelines, MedDRA and proprietary safety databases (e.g. Argus).
- Strong experience in PV processes for vendor oversight, individual case management, aggregate data review, aggregate reports, and audits/inspections.
- Ability to navigate in a matrixed environment, motivate and influence others, and effectively interact with critical internal and external stakeholders.
- Proficiency in English both written and spoken, and excellent written and verbal communication skills with the ability to interact across multiple functions worldwide.
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 $160,000 - $240,000. 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.
