Add

Fix term 9 months contract Drug Safety Associate

Our renowned client based in the Hertfordshire area is looking for a Drug Safety Associate to join their team on a 9 months fix term contract.

Purpose: To be responsible for the efficient collection, processing and follow up of UK adverse event reports, to meet compliance with MHRA and Maltese Health Authority.

To ensure information relating to adverse events (non serious and serious UK cases) is collected and recorded in a timely fashion according to local/global SOPs

�Anonymised Single Patient Reports received and processed (MHRA portal)

�Ancillary documentation accompanying adverse event reports reviewed and relevant information identified for data capture

�New cases/ queries set up accurately on Advent Tracking

�Clinical SAEs initiated and forwarded to PDS Regional Centre Europe within time lines, tracking and requesting queries from clinical trial sites as requested by RCE

�Reconciliation of solicited cases, cases received from Medical Information or Professional Information, and cases received from QA (PDRQ)

To process cases efficiently and submit all reportable cases to the appropriate regulatory body in compliance with their reporting requirements and time lines

�Clear and accurate data capture of adverse event cases and appropriate medical assessment (including labeling) of single AE reports in accordance with departmental conventions/guidelines and SOPs

�All reportable cases processed and submitted to the MHRA and the Maltese Health Authority in compliance with their reporting requirements

�As appropriate, reportable cases submitted to EMEA

�Queries responded to within an appropriate time line: stakeholders kept updated

To ensure that all adverse event reports are completed and followed up appropriately

�Issues related to UK adverse event reports resolved in collaboration with internal/ external UK DSC contacts

�Appropriate method of follow up used to obtain additional information from reporters (both consumers and healthcare professionals)

�Issues with new or ongoing cases identified and escalated to Manager UK DSC or Senior Drug Safety Specialist (SDSS)/Drug Safety Specialist (DSS), as appropriate

To support the Drug Safety department in ensuring high standards are maintained and opportunities for departmental improvements are identified and implemented

To ensure that personally and within the team:

1.high ethical standards are maintained at all times

2.there is full compliance with all applicable laws, regulations, industry codes and internal policies and procedures

�Awareness of and compliance to laws and regulations applicable to business area

�Awareness of and compliance to all company policies and procedures including HR, Finance, Procurement, IT and Legal

�Awareness of and compliance to all relevant industry codes and guidelines, in particular ABPI Code of Practice

�Demonstrable ownership of comprehensive understanding of regulations and SOPs: Learning gaps identified and actions taken to access required training

�Attendance at all requisite training sessions and completion of all requisite on-line training and compliance programmes within specified time limit

Desirable Knowledge and Experience:

�Qualified pharmacist, relevant nursing qualification, life sciences degree or relevant experience in drug safety.

�Knowledge of drug safety regulatory obligations

�Good knowledge of medical terminology

�Experienced at writing clear, concise, unambiguous medical text

�Computer literacy essential