Drug Safety Scientist

The Drug Safety Scientist will be required on a 12 month contract joining this global pharmaceutical based around the M4 corridor.

The role will include the following:

- Safety Management and Reporting.
- The coordination of safety reporting requirements as required for MAH and/or study sponsor, as applicable.
- Collection, review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study, Local Health Authorities (LHAs) and other potential sources.
- Assist with initial quality review and assessment of individual cases.
- Co-ordinate/perform the follow-up of missing information from the AE reporter.
- Provision of local data as required to support the preparation of Safety Summary reports (PSURs, ASR, etc).
- Assist in the implementation of compliance standards and facilitate the collection of compliance metrics as required.
- Ensure that day-to-day PV functions are performed satisfactorily and that full regulatory compliance is maintained at the Local Operating Company (LOC) level.
- Awareness of and familiarity with industry principles of drug development and pharmacology.
- Good verbal and written communication skills.
- Ability to negotiate and communicate with internal and external customers.
- Biological sciences degree and/or equivalent proven expertise and experience in pharmaceutical regulations and R&D processes.

To find out more about Real Staffing please visit www.realstaffing.com