We are recruiting for a Drug Safety Scientist to join a Pharmaceutical company in Buckinghamshire on a contract basis.
You will be responsible for coordinating the safety reporting and the collection, review and reporting of Adverse Events. Awareness of and familiarity with industry principles of drug development and pharmacology is required. A life science degree and/or equivalent proven experience in pharmaceutical regulations and R&D processes is required.
- 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 supporting the preparation of Safety Summary reports (PSURs, and ASR).
- 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.
Successful candidates will enjoy the benefits of working with a global Pharmaceutical company, including a COMPETITIVE RATE.
Qualifications and Experience:
- 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.
For more information or to apply for this Drug Safety Scientist position, please contact Hendre Moolman on 01438 870 023 or email firstname.lastname@example.org. Please quote reference CL21610 in all correspondence.