Responsibilities and Duties- Responsible for supporting all safety science activities across Rhythm products in clinical development and post-approval stages ensuring the delivery of high-quality safety data.
- Lead ongoing safety surveillance activities, analysis, and interpretation of accumulating aggregate safety data from clinical trials and post-marketed sources in accordance with PV procedures, regulatory requirements and timelines.
- Identify, evaluate and manage emerging safety signals, maintain good documentation, and communicate any changes in the safety profile or benefit-risk assessment effectively (written and verbal) both internally and externally.
- Ensure consistent presentation of safety and risk management topics across various regulatory documents and enhance safety data quality and data integrity for all Rhythm products.
- Lead/co-lead 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).
- Provide input to clinical study documents, including protocols, Investigators Brochures, clinical study reports, and regulatory documents/responses.
- 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- Minimum of a bachelor's degree in Medicine, Pharmacy, Nursing, Epidemiology, Biomedical Sciences, or equivalent healthcare degree.
- 8+ years of relevant drug safety/PV experience is required.
- 3+ years of PV safety science experience including signal detection and management, risk-benefit evaluation, risk mitigation and minimization strategies is preferred.
- Expert knowledge of global PV requirements, Good Pharmacovigilance Practices, ICH Guidelines, MedDRA and proprietary safety databases (e.g. Argus).
- Highly organized, results-driven, self-motivated and critical thinker who can synthesize, organize, manage, and communicate safety data from multiple sources.
- 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 will 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.
