PV Officer / Senior PV Associate
New
C
ClinigenPharmacovigilance
Malaysia. Croatia. Applicants based in EU and South Africa are also welcome.Full-TimeMiddle
Salary not disclosed
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Job Details
- Required Skills
- Data AnalysisMS Office
Requirements
- Healthcare Professional qualification or equivalent of a Batchelor of Science (BSc) degree.
- Previous experience in Clinical Safety Case Processing.
- Demonstrated ability to build relationships with internal and external customers.
- Strong attention to detail and ability to work in an environment with tight timelines.
- Excellent organizational, prioritization, and analytical/problem solving skills.
- Excellent oral and written communication skills.
- Extensive knowledge of MS Office Applications and systems.
- Ability to work collaboratively within a matrix and/or cross-functional environment.
- Self-motivated with the ability to work unsupervised.
- Ability to evaluate and present complex safety data applying sound judgement.
Responsibilities
- Assess and process serious adverse events (SAEs) and Individual Case Safety Reports (ICSRs) into the Global Drug Safety database.
- Manage mailboxes and respond to data entry/case processing queries from Clients and Partners.
- Perform triage, tracking, and forwarding of safety data from Managed Access Programmes.
- Prepare and submit cases to Regulatory Authorities and handle E2B/R3 format reporting.
- Conduct quality-control of cases and perform reconciliation activities per Client Operating Guidelines.
- Perform Literature Article reviews and follow-up activities.
- Support departmental regulatory inspection preparedness and participate in audits.
- Support the collation and dissemination of quality and compliance metrics.
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