Senior Safety Science Lead, Pharmacovigilance

rhythmpharmaceuticals

Boston (MA)

Hybrid

USD 160,000 - 240,000

Full time

13 days ago
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Job summary

Rhythm Pharmaceuticals seeks a senior pharmacovigilance leader based in Boston to oversee safety surveillance across clinical development and post‑approval stages. You will guide global PV activities, ensure high-quality data, and manage safety reporting in line with ICH and GVP standards.

The role requires mentoring junior staff and coordinating with cross‑functional teams, with a hybrid work model in Boston and occasional travel.

Qualifications

  • Bachelor’s degree in a healthcare field.
  • 8+ years of drug safety/PV experience.
  • 3+ years in PV safety science including signal detection and risk management.

Responsibilities

  • Lead safety surveillance across clinical development and post-approval stages.
  • Identify and evaluate emerging safety signals with thorough documentation.
  • Coordinate preparation of global PV documents (PBRERs, PSUR, DSUR, RMP).
  • Provide input to clinical study documents and regulatory responses.
  • Mentor PV staff and vendors; drive process improvements and compliance.

Skills

Drug safety
PV processes
Regulatory knowledge
Signal detection
Data interpretation

Education

Bachelor's degree in Medicine or healthcare

Tools

Argus
MedDRA

Job description

Rhythm Pharmaceuticals seeks a senior pharmacovigilance leader based in Boston to oversee safety surveillance across clinical development and post‑approval stages. You will guide global PV activities, ensure high-quality data, and manage safety reporting in line with ICH and GVP standards.

The role requires mentoring junior staff and coordinating with cross‑functional teams, with a hybrid work model in Boston and occasional travel.

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