
Data Analyst Professional
2 weeks ago
We are seeking a detail-oriented Data Officer to join our dynamic team. This role involves contributing to activities performed in the Hub, requiring close collaboration and excellent time management skills.
- Perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for clients, according to agreed timelines.
- Manage generic or client-specific email boxes as required.
- Register, triage, assign and coordinate the processing of vigilance cases.
- Follow-up requests with local reporters.
- Respond to queries from clients and reporters.
- Carry out periodic reconciliations to confirm proper handling of all vigilance reports for clients.
- Support pharmacovigilance (PV) activities as needed.
- Participate in audits / inspections and resulting action plan.
- Bachelor's or Master's degree in Medicine, Pharmacy, nursing, or science-related field, or equivalent experience.
- 2+ years' experience in pharmacovigilance working for service providers performing data entry and QC of cases.
- Previous experience working under deadlines.
- Client communications.
- Knowledge of US and EU PV regulations.
- Strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
- Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
- Excellent organizational and interpersonal skills.
- Ability to work well within a team.
- Excellent time management skills.
- Accountability and autonomy with assigned tasks.
- Process-orientated with good attention to detail.
- Effective communication skills for explaining complex concepts.
- Flexibility and adaptability to handle a dynamic workload.
- Works well under pressure and meeting deadlines.
- Safety database experience.
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