Hobson Prior are looking for a Senior Safety Specialist to join a research-based biopharmaceutical company who are focused on the discovery and development of pioneering medicines. As the Senior Safety Specialist, you will take part in Study Management Teams and be accountable for PVE input and operational support in clinical trial activities.
- You will establish work priorities and direction with minimal input from Manager.
- You will participate in Study Management Teams.
- Develop drug safety presentation for investigator meeting presentations.
- Training of CRO and investigators.
- You may lead and manage functional projects or work streams (e.g. monitoring CRO activities).
- May represent as a point of contact to other functions in the organization or CRO’s.
- Complete study unblinding.
- Perform clinical trial reconciliation independently.
- Have solid working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports.
- Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate.
- Will interact with other PVE functional areas to process adverse events efficiently and reliably.
- Excellent interpersonal and communication skills, both written and oral.
- Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).
- Ability to assess data and understand the medical/safety implications.
- Ability to follow guidelines and procedural documents.
- Demonstrated success working both independently and in collaboration with others.
- Systems analyst experience in the pharmaceutical industry preferably in Drug Safety B.Sc. in a related life sciences field.
- Case processing experience is required.
- Prior knowledge and experience with safety reporting and regulatory compliance.
- Understands safety database structures and is familiar with data retrieval tools.
- Knowledge of clinical trials activities preferred.
- Safety database and data entry experience would be preferred.
- Understanding of medical terminology and the ability to summarize medical information required.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.