
Medical Case Analyst
7 days ago
As a specialist in case management, you will play a pivotal role in our dynamic team.
Key Responsibilities:- Enter vigilance cases into relevant databases while adhering to established conventions and guidelines.
- Perform quality control on vigilance cases and associated documents for safety reports.
- Conduct medical reviews of vigilance cases according to relevant conventions and regulatory requirements.
- Follow up on requests regarding vigilance cases via phone or mail.
- Conduct preliminary analysis of complex cases prior to data entry.
- Determine submission requirements for safety cases.
- Prepare ICSR/MLM filters as required.
- Review and analyze ICSRs obtained from competent authorities' databases.
- Perform reconciliations among partners, medical information, and quality complaints.
- Participate in operational implementation of new projects.
- Act as a key contact for projects under the support of the team leader/activity manager/project manager.
- Conduct medical review of post-marketing cases assigned.
- Lead operations for assigned post-marketing clients.
- Develop and update technical agreements/safety management plans/client templates.
- Develop and update SOPs/WPDs/trainings and other related documents.
- Participate in process implementation/maintenance/improvement.
- Possess a Pharmacist or Life Sciences degree with more than 3 years of experience in Pharmacovigilance.
- Client communication skills are essential.
- Experience working under deadlines is crucial.
- A minimum of 3 years of experience working for service providers performing QC of cases is required.
- Pharmaceutical background with a strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety is necessary.
- In-depth knowledge of pharmacovigilance principles, adverse event reporting, and causality assessment is vital.
This role offers an exciting opportunity to work in a dynamic environment and develop your skills in pharmacovigilance. If you have a passion for delivering high-quality results and are committed to excellence, we encourage you to apply for this challenging position.
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