p DRUG SAFETY ADMINISTRATOR - PERMANENT, MILTON KEYNES /p p Salary £27-£28K /p p br /p p Our Client is looking to recruit a Drug Safety Administrator to join their team /p p This is a Technical Role for persons with a strong life science degree, degree in pharmacy and nursing qualifications. /strong For this title, the Drug Safety Administrator desirable to have at least 1 year of experience as a Drug Safety Administrator or can be a recent graduate. The Drug Safety Administrator shows an understanding of the Quality Management Process with a good knowledge and understanding of applicable company policies, procedures and working practice documents. /p p br /p p strong KEY RESPONSIBILITIES TASKS /strong /p ul li For scenarios or projects that fall outside the scope of their technical, clinical or medical expertise should be escalated or in certain circumstances pre-checked by a senior or more technically qualified colleague before final release. /li li Keeping the Pharmacovigilance Manager fully informed of problems and issues that may arise related to the product, adverse events, the patients, prescribers or the marketing authorisation holder. /li li In the absence of Drug Safety Associate, the Drug Safety Administrator escalates these issues to a senior or more technically qualified staff member for their clinical input and guidance, as required. /li li Upload ProQuest alerts for assigned active ingredients into the Literature Monitoring System (LMS). Identifying case reports and important safety information/published studies in the LMS database. /li li Processing selected case reports in the ICSR database. /li li Checking all literature case reports have the appropriate AE terms assigned for MedDRA coding. Notifying the QPPV of cases where the appropriate MedDRA term cannot be identified independently. /li li Reconciliation both with clients and/or with PV partners on behalf of clients (as required). /li /ul p br /p p strong Screening of Published Literature the MLM Service /strong /p p strong Individual Case Safety Reports /strong /p ul li Processing ICSR reports from any source in the drug safety database. /li li Attaching source documents with each case on the drug safety database. /li li Exchanging a PV case reference from the ICSR database and exchanging these with PV partners. /li li Conducting follow–up investigation for direct reports from either patients or healthcare professionals. Exchanging a PV case reference from the ICSR database and exchanging these with PV partners. /li li Conducting follow–up investigation for direct reports from either patients or healthcare professionals. /li /ul p br /p p strong Qualifications – /strong /p p The ideal person will must have a Life Science Degree either a recent graduate looking to secure their second job, or has a nursing degree or experience /p p Please note only CV’s with these qualifications or experience will be considered. /p p Has a life science degree and is either a recent graduate or looking to secure their second job. /p p Candidates must be located within commuting distance of either Bedfordshire, Buckinghamshire, or Northamptonshire. /p
Read Less
