Drug Safety QA Associate

ProClinical Ltd
12 Jan 2018
11 Feb 2018
Contract Type
Full Time
ProClinical have a new vacancy at a pharmaceutical company working in research and development of highly effective and innovative medications. This job vacancy is for a Drug Safety QA associate to join their team at their Cambridgeshire offices. The company is one of the industry's most well-known brands and specialises in R&D in 3 major areas; respiratory, oncology and inflammation.

This role will support the Head of Quality Management in the maintenance of the MDSP Quality Management system with respect to compilation of performance and compliance metrics; monitoring of Key Performance Indicators (KPIs), general compliance and performance monitoring and management of the MDSP CAPA system.

Job Responsibilities include:

* Independent monitoring of compliance and performance reports
* Independent compilation of those data for monthly/quarterly compliance reports
* Preparation of compliance metrics/KPIs for compliance reports, for the monthly compliance meeting and for inclusion within the company's Pharmacovigilance System Master File (PSMF)
* Identification of "late submissions" and other incompliances
* Preparing graphical displays of compliance data
* Bi-monthly QPPV reports; and IAC ICSR submission reports (monthly)
* Identifying the need for a CAPA using for example the standard weekly/monthly compliance reports
* Initiating the CAPA and requesting its completion from other MRL functions, IACs or third parties and following up as required to ensure timely completion;
* Maintaining oversight of the CAPA preparation process and providing advice on completion of the standard CAPA form;
* Review all CAPAs prior to finalization to ensure that they are clear and that appropriate corrective and preventive actions have been described;
* Finalisation and archiving of CAPA documentation ready for audit/inspection purposes;
* Manage the preparation and finalisation of CAPAs requested by third parties or other IACs; and
* Interaction with the other Drug Safety Centres with respect to CAPA finalisation and exchange.
* Participate in the implementation (set-up) of an international/worldwide electronic CAPA System.
* Participate in the regular MDSP Compliance Meeting to provide the Head of QM and others with oversight of late cases to Regulatory Authorities, IACs and third parties.
* Review and analysis of all CAPAs to identify clusters and potential trends. These shall be notified to the Head of QM, Head of DSO and QPPV during regular meetings to allow implementation of appropriate preventative actions.

Skills and Requirements:

* Professional background in Pharmacovigilance and/or Quality Management
* Knowledge of pharmacovigilance regulatory requirements e.g. reporting timelines to Regulatory Authorities
* Basic knowledge of medical terminology
* Experience (hands on) in basic IT applications, use of databases, good knowledge of MS Office
* Ability to work in an international environment
* Able to plan, organise and monitor activities according to priorities
* Proactive and confident approach to all tasks
* Able to apply an analytical approach to identify actions
* Diligent and reliable, with a pronounced sense of responsibility
* Excellent attention to detail
* Well-structured and organised, target focussed
* Team oriented working style/ team player
* Able to demonstrate a flexible approach, show motivation and have the ability to work under pressure
* Consistently demonstrates and encourages others to demonstrate the Company's Core Values; Honesty, Respect, Passion, Innovation, and Commitment.
* Strong ethical standards and a high level of personal integrity.
* Adheres to the Company's Compliance and Code of Business Ethics guidelines.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on Phone number removed or upload your CV on our website - URL removed
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.