Drug Safety Associate

PRA Health Sciences
Swansea (Abertawe)
17 Jun 2017
23 Jun 2017
Company description: As a top five CRO, we have worked on 100 marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45 such drugs. At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace. At PRA, borders do not create boundaries. PRA's success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages - yet operate in unison as one worldwide PRA community. Job description: We are seeking an experienced Drug Safety Associate to join our established Drug Safety department in Swansea, UK. The role of a Drug Safety Associate involves managing individual case reports (Serious Adverse Events, Adverse Drug Reactions), reconciliation of SAEs, coding and data retrievals from the safety database, supporting the generation of periodic safety reports, and DSMB/DMC reviews. Within this role, your responsibilities will include: •Producing concise and accurate narratives •Performing coding of diseases, adverse events and medications •Submission of safety reports to the relevant authorities •Processing individual case safety reports •Reconciliation of Serious Adverse Events •Generating data listings from the safety database Required profile: The ideal candidate will have an undergraduate degree (or equivalent) preferably within life sciences and the ability to read, understand and summarise medical source documents. An understanding of regulations relevant to safety of drugs in development and post authorizations, as well as knowledge of clinical research, is an advantage. We can only consider experienced clinical safety associates with CRO or pharma background for this role. What we offer: Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. This job was originally posted as www.totaljobs.com/job/74189343