Senior Safety Science Lead – Pharmacovigilance & Risk

Rhythm Pharmaceuticals Inc.; Boston (MA); Hybrid; USD 160,000 - 240,000; Full time

Benefits offered by this job

Discretionary annual bonus

Hybrid work model

Benefits including RSUs

Job summary

Rhythm Pharmaceuticals Inc. in Boston seeks a senior professional to lead safety science across clinical development and post-approval stages. You will deliver high-quality PV data and oversee safety signal detection, assessment, and reporting.

You will guide global PV documents (PBRERs, PSURs, DSURs, and RMPs), input into study protocols and regulatory responses, and mentor junior staff, while navigating a matrixed organization and a hybrid work model with occasional travel.

Qualifications

• Bachelor’s degree in Medicine, Pharmacy, Nursing, Epidemiology, or equivalent.
• 8+ years of drug safety/PV experience required.
• 3+ years in PV safety science including signal detection and risk management preferred.
• Expert knowledge of global PV requirements, ICH Guidelines, MedDRA and safety databases.

Responsibilities

• Support safety science activities across Rhythm products in development and post-approval stages.
• Lead safety surveillance activities, analysis and interpretation of safety data.
• Identify, evaluate and manage emerging safety signals and communicate changes.
• Ensure consistent presentation of safety topics in regulatory documents and improve data quality.
• Lead/co-lead planning of PBRERs, PSURs, DSURs, and RMPs.
• Provide input to protocols, ICHDs, reports and regulatory responses.
• Participate in PV team planning, audits, SOP development, and process improvements.
• Mentor Rhythm PV staff and vendors; stay abreast of PV regulatory changes.

Skills

PV experience

Safety science

Global PV knowledge

Communication skills

Cross-functional collaboration

Education

Bachelor's degree in Medicine, Pharmacy, Nursing, Epidemiology, Biomedical Sciences

Tools

Argus

MedDRA

Job description

Rhythm Pharmaceuticals Inc. in Boston seeks a senior professional to lead safety science across clinical development and post-approval stages. You will deliver high-quality PV data and oversee safety signal detection, assessment, and reporting.

You will guide global PV documents (PBRERs, PSURs, DSURs, and RMPs), input into study protocols and regulatory responses, and mentor junior staff, while navigating a matrixed organization and a hybrid work model with occasional travel.