
Diligent Case Specialist
1 day ago
We are seeking a diligent and detail-oriented Case Specialist to join our team. As a Case Specialist, you will play a pivotal role in various activities performed in the Hub.
Your key responsibilities will include data entry of vigilance cases, quality control of cases and associated documents, medical review of cases, follow-up requests by phone/mail, pre-analysis of complex cases, identification of submission requirements, review and analysis of ICSRs, performing reconciliations, participation in project implementation, key contact for projects, and drafting/updating of technical agreements and SOPs.
This is an excellent opportunity for individuals with a strong background in pharmacovigilance (PV) to showcase their skills and contribute to the success of our organization.
Responsibilities:
- Data entry of vigilance cases
- Quality control of cases and associated documents
- Medical review of cases
- Follow-up requests by phone/mail
- Pre-analysis of complex cases
- Identification of submission requirements
- Review and analysis of ICSRs
- Performing reconciliations
- Participation in project implementation
- Key contact for projects
- Drafting/updating of technical agreements and SOPs
Requirements:
- Pharmacist or Life Sciences degree
- More than 3 years experience in PV
- Previous experience working to deadlines
- Client communications
- Minimum 3 years experience working for service providers performing QC of cases
- 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
Benefits:
- Excellent compensation package
- Ongoing training and development opportunities
- Collaborative and dynamic work environment
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