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Talent Groups

Pharmacovigilance Specialist

Talent Groups, Waltham, Massachusetts, United States, 02254

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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