
Senior Clinical Operations Specialist
1 week ago
The ideal candidate will have a strong background in pharmaceuticals, with a deep understanding of pharmacovigilance principles, adverse event reporting, and causality assessment. A minimum of 3 years experience working for a service provider performing quality control of cases is required.
This role involves data entry of vigilance cases in relevant databases according to relevant conventions, as well as quality control of vigilance cases and other documents associated with safety reports. The successful candidate will also be responsible for medical review of vigilance cases according to relevant conventions and regulatory requirements.
A key contact for projects, the operations lead will work closely with the team leader/activity manager/project manager to ensure smooth implementation of new projects. Strong communication skills are essential for this role, with the ability to draft and update technical agreements/safety management plans/client templates, SOPs/WPDs/trainings, and other related documents.
Participation in the implementation/maintenance/improvement of processes is also a critical aspect of this role. The successful candidate will be expected to contribute to the operational activities performed in the hub and participate in the development and implementation of business strategies.
Requirements- Pharmacist or Life Sciences degree with 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, causality assessment
- Data entry of vigilance cases in relevant databases according to relevant conventions
- Quality control of vigilance cases and other documents associated with safety reports
- Medical review of vigilance cases according to relevant conventions and regulatory requirements
- Follow-up requests of vigilance cases by phone/mail
- Pre-analysis of complex cases before data entry
- Identification of submission requirements for safety cases
- Identification of requirements in terms of preparation of ICSR/MLM filters
- Review and analysis of ICSRs downloaded from competent authorities databases
- Performing reconciliations (partners, medical information, quality complaints)
- Participation in the operational implementation of new projects
- Key contact for projects (with support of the team leader/Activity manager/Project manager)
- Drafting/updating of technical agreements /safety management plan /client template
- Participation in the implementation/maintenance/improvement of processes
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