Pharmacovigilance Specialist Job at Talent Groups, Waltham, MA

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  • Talent Groups
  • Waltham, MA

Job Description

Job Description

The Pharmacovigilance Scientist will support safety surveillance and signal management activities across clinical and post-marketing products. This role partners closely with PV Physicians and cross-functional teams to manage risk, contribute to regulatory deliverables, and ensure compliance with global pharmacovigilance requirements.

Key Responsibilities:

  • Support product safety surveillance and signal detection activities
  • Contribute to risk management plans (RMPs/REMS) and benefit-risk assessments
  • Perform safety data analysis and author safety documentation
  • Support aggregate reporting (DSURs, PSURs, PADERs)
  • Provide PV input to clinical and regulatory documents
  • Collaborate with cross-functional and vendor partners

Qualifications:

  • Life sciences or healthcare degree
  • 2–4 years of pharmacovigilance experience
  • Experience with safety reporting and MedDRA
  • Strong communication, analytical, and organizational skills

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