Drug Safety Scientist

Hobson Prior are currently working with a global pharmaceutical organisation who are driven to help improve and prolong life. Our client is seeking Drug Safety Scientist to join them on a contract basis in Darmstadt.

Job Responsibilities:

• DSUR, PBRER and pSUSAR preparation/project management/ writing up.
• Literature review processes; be able to understand the publications and highlight potential signals or important efficacy information.
• Use ArisG or other safety databases to generate CIOMS and/or review.
• Safety data review using spotfire or other visualization tool at clinical level and for integrated data.
• Knowledge of general case processing and expedited reporting activities.
• Surveillance related project management activities (slide preparation for safety committees and boards, meeting minutes., etc).
• Safety evaluation report writing by applying principles such as Bradford Hill criteria, CTCAE etc.,
• Knowledge and experience of CIOMS, GVP, FDA and ICH guidelines.
• Understanding of AESI, CMEs, DMEs and activities surrounding these topics.
• Project management activities.

Key Skills:

• Collaborative
• Communication; clearly express ideas/position.

Requirements:

• You will have at least 6 years in drug safety/pharmacovigilance, including experience with case review/processing.
• Early and post-marketing experience.
• Have previously worked in a Global environment.
• Experience with oncology drugs is admirable.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.