Senior Safety Surveillance & Risk Scientist
A global biotechnology company is advertising a vacancy for an Senior Safety Surveillance & Risk Scientist to work with their UK team on a remote basis. The institution is known for their work discovering, developing, and delivering innovative therapies for patients with serious neurological and neurodegenerative diseases across the globe. This position is an excellent opportunity to work with an organisation that has cultivated a strong presence in the biotechnological industry and prides itself on its world-class manufacturing facilities.
- Leading the signal management process for assigned product(s) and evaluating safety data and signals as part of ongoing pharmacovigilance activities.
- Synthesising data from multiple sources and authoring signal evaluation reports.
- Leading signalling review process and product Safety Signalling Team meetings.
- Managing literature review for safety information.
- Collaborating with Global Safety Officers and other Safety Physicians for assigned investigational programs, including clinical trial activities (protocol review, ICF review, etc.) safety committee management, data analysis, signal detection, ad hoc requests, and other product activities as assigned.
- Leading process for responding to safety questions from regulatory authorities.
- Contributing to and leading initiatives for process improvement and consistency regarding aggregate reporting, clinical trial safety oversight, and signal management and responding to ad hoc safety questions.
- Leading and collaborates with Aggregate Reports on strategy, review, and finalisation of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).
Skills and Requirements:
- Demonstrable education and experience in a similar and/or relevant capacity.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Hansberry at +44 207 440 0636 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.