Local Case Intake Advisor, GBS Patient Safety - French Language (12 month FTC)
Core
Manage the intake and processing of Individual Case Safety Reports (ICSRs) and adverse event reports to ensure compliance with pharmacovigilance regulations and support safe medicine use.
Role type
Local Case Intake Advisor (Pharmacovigilance)
Builds
High-quality pharmacovigilance operations and safety data for designated Marketing Companies
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Required skills
Pharmacovigilance (PV) knowledge, Health Authority regulations expertise, Regulatory database screening, Literature search, Quality Management Systems (QMS) management, Product quality complaint (PQC) handling, Data reconciliation, SOP adherence
Preferred skills
Audit and inspection experience, Therapeutic area knowledge, Project management, Safety systems familiarity (e.g., Argus)
Technologies
Argus, Regulatory databases
Responsibilities
Manage and process adverse event reports and ICSRs from post-marketed sources, Support Health Authority interactions and queries, Review and assess safety data in line with regulatory requirements, Contribute to Quality Management Systems and audit readiness, Conduct literature searches and regulatory database screening, Identify and manage product quality complaints (PQC), Perform data reconciliations, Collaborate with local Patient Safety teams and cross-functional stakeholders
Seniority
Individual Contributor, Operational Level