Pharmacovigilance Officer - 6 months contract
In this role, you will provide technical and administrative support to the Pharmacovigilance and Clinical Safety team on a day to day basis as needed. The Pharmacovigilance Officer will report to the Director, Head of Clinical Safety & Pharmacovigilance.
Your main responsibilities:
- Ensure update of the safety database:
- e-TMF filing for on-going studies and also previous studies
- Transfer of SAE data from a CRO safety database to Debiopharm Safety database
In addition, you will replace the Clinical Safety Officer and :
- Ensure the processing of AEs according to the SOPs and study specific Safety Monitoring Plan
- Ensures vendor is in compliance with DPI SOPs and quality requirements for triage of AEs, data entry into the safety database, coding of events and narrative writing
- Perform QC for SUSARs and reports SUSARs to EMA using the Eudravigilance system, to Ethics committees and to investigators
- Ensure reconciliation of safety data between the Clinical and Safety databases in collaboration with our license partners when applicable
- Ensure communication with our license partners according to the SDEA : transfer of cases, performs reconciliations and answers to partner’s requests for additional information (queries)
- Life Science graduated, or equivalent nursing or medical degree level or equivalent in a relevant discipline
- Previous experience working in the conduct of clinical trials and safety management in clinical trials in pharmaceutical industry of CROs
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Excellent interpersonal, written and verbal communication skills. Good IT skills with good industry knowledge.
- Team spirit and strong service orientation.
- Fluent English.