
Medical Case Specialist
1 day ago
Job Title: Medical Case Specialist
We are seeking a skilled professional to contribute to our team in the area of pharmacovigilance.
Responsibilities:- Data Entry: Enter safety cases into relevant databases according to established conventions.
- Quality Control: Review and verify safety case documents for accuracy.
- Medical Review: Conduct medical reviews of safety cases according to regulatory requirements.
- Follow-up Requests: Follow up on safety cases via phone or mail.
- Pre-analysis: Perform pre-analysis of complex cases before data entry.
- Submission Requirements: Identify submission requirements for safety cases.
- ICSR/MLM Filters: Identify requirements for preparation of ICSR/MLM filters.
- Review and Analysis: Review and analyze ICSRs downloaded from competent authorities databases.
- Reconciliations: Perform reconciliations with partners, medical information, and quality complaints.
- Project Implementation: Participate in the operational implementation of new projects.
- Key Contact: Serve as key contact for projects with support from the team leader/activity manager/project manager.
- Post-Marketing Cases: Perform medical review of post-marketing cases assigned.
- Operations Lead: Act as Operations lead for assigned post-marketing clients.
- Technical Agreements: Draft and update technical agreements/safety management plans/client templates.
- SOPs/WPDs/Trainings: Draft and update SOPs/WPDs/Trainings and other documents directly related to their activity.
- Process Improvement: Participate in the implementation/maintenance/improvement of processes.
- Pharmacist or Life Sciences degree with more than 3 years experience in Pharmacovigilance (PV).
This is an excellent opportunity to work in a dynamic team and contribute to the success of our organization. The successful candidate will have the opportunity to develop their skills and knowledge in pharmacovigilance and make a meaningful contribution to the industry.
Others:The ideal candidate will have strong communication and organizational skills, be able to work independently and as part of a team, and have a strong understanding of regulatory requirements related to drug safety.
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