
Data Governance Specialist
2 weeks ago
Job Title: Data Governance Specialist
We are seeking a dynamic professional to join our team as a Data Governance Specialist contributing to activities performed in the hub.
Responsibilities:
- Perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow-up of all safety information received for clients.
- Manage generic or client-specific email boxes as appropriate.
- Register, triage, assign and coordinate vigilance cases.
- Follow-up requests with local reporters.
- Respond to queries from clients and reporters.
- Carry out periodic reconciliations confirming proper handling of vigilance reports for clients.
- Support and contribute to local pharmacovigilance activities performed by the Local Safety/PV department as needed.
- Participate in audits/inspections and resulting action plans.
Requirements:
- Bachelor's or Master's degrees in Medicine, Pharmacy, Nursing, or Science-related fields, 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 communication skills.
- Knowledge of US and EU PV regulations.
- Pharmaceutical background, strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
- Deep knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment.
Skills:
- Excellent organizational and interpersonal skills.
- Ability to work well within a team.
- Excellent time management skills.
- Accountability and autonomy with assigned tasks.
- Process-oriented with good attention to detail.
- Effective communication skills both written and verbal.
- Flexibility and adaptability to handle dynamic workloads.
- Works well under pressure and working to timelines.
- Safety database experience.
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