Actalent · 2 days ago

Pharmacovigilance Manager

Parsippany, NJ

Contract

Hybrid

Senior Level

3+ years exp

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Responsibilities

Medical review of ICSRs.

MedDRA coding

Expectedness assessment.

Causality Assessment and Company Comment.

MedWatch and CIOMS review.

Overview of compliance in relation to the quality, completeness and timeliness of ICSRs.

Aggregate reports

Preparation of yearly schedule of periodic reports.

Ensure that all pharmacovigilance documents are prepared in time and are quality controlled.

Overview of compliance in relation to the quality, completeness and timeliness of aggregate reports.

Signal Detection activities

Qualification

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Pharmaceutical Industry KnowledgeEnglish Language ProficiencyMedical TerminologyMS Office ProficiencyMS ExcelProblem-SolvingCommunicationTime Management