Pharmacovigilance Associate I (serbia)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Pharmacovigilance Associate I (PV Associate I) to join our A-team (hybrid*/remote). As a PV Associate I at Allucent, you are responsible for coordinating, administering, and maintaining the logistical aspects of pharmacovigilance activities in clinical trials to ensure an effective and accurate collection, database entry, review and reporting of safety data of Allucent Pharmacovigilance.

In this role your key tasks will include:

• Create/maintain study-specific forms for collection of safety data (SAE forms, etc.)
• Document potential serious adverse event (SAE) information during intake of calls/email/fax
• Collect SAE forms from sites in cooperation with CRA(s) & review SAE forms received and determine if a follow-up query is required
• Contribute to the performance of initial safety review and triage of SAEs to determine seriousness, expectedness and priority, including the timeline for response
• Review and perform quality check of safety narratives summarizing all relevant medical information for individual case safety reports
• Contribute to the performance of coding review of data from clinical study databases using standardized medical dictionaries (such as MedDRA)
• Liaise with the data management department to obtain required safety data and to provide safety input when required
• Support reconciliation of clinical and safety databases
• Collect and perform quality control of safety documents to be reported to regulatory authorities, ethical committees and sites
• Submit safety documents to regulatory authorities and ethical committees according to regulatory requirements including the generation of safety letters & create/maintain study tracking logs for regulatory submissions
• Actively support staff learning and development within the company
• Draft and contribute as Subject Matter Expert (SME) in the field of PVA activities to the evaluation/improvement of processes and procedures within the Quality Management System
• Assure good communication and relationships with (future) clients
• Contribute and take part in client evaluations, visits and bid defenses
• File and archive safety documents
• Support of other medical affairs activities as required
• Contribute to the development and maintenance of standard operating procedures (SOPs)
• Provide basic safety training to new staff and at Investigator Meetings
• Contribute to the improvement of departmental processes
• Contribute to other areas of business as required