Drug Safety & Pharmacovigilance Specialist — Signals & Reporting

Yoh Services LLC

Cambridge (MA)

Presencial

USD 95 000 - 135 000

Tempo integral

14 dias+

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Vantagens oferecidas por esta oferta de emprego

Medical, Prescription, Dental & Vision

Health Savings Account (HSA)

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Certification and training

Resumo da oferta

Yoh Services LLC is seeking a Drug Safety & Pharmacovigilance Specialist to work onsite in Cambridge, MA. The role focuses on authoring aggregate safety reports, managing line listings, and supporting signal detection, risk management, and data analysis across therapeutic areas.

The ideal candidate has 3–5 years in pharma/biotech, familiarity with regulatory safety reporting, and experience with safety databases like Argus or Arisg.

Qualificações

3–5 years in pharma/biotech with drug safety/pharmacovigilance experience.
Experience supporting aggregate safety reporting, signal management or risk management.
Knowledge of global safety reporting requirements and pharmacovigilance regulations.

Responsabilidades

Collaborate with leads to author aggregate safety reports (PSURs, DSURs and line listings).
Oversee line listings from generation through submission.
Develop and edit safety management plans and related documents with regulatory teams.

Conhecimentos

Pharmacovigilance

Data analysis

Cross-functional collaboration

Regulatory knowledge

Scientific writing

Formação académica

Medical/Healthcare or life sciences degree

Ferramentas

Argus

Arisg

Empirica

Spotfire

Descrição da oferta de emprego

The ideal candidate has 3–5 years in pharma/biotech, familiarity with regulatory safety reporting, and experience with safety databases like Argus or Arisg.

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