Safety Quality & Compliance, PSMF Specialist - Europe

INC Research UK Limited
United Kingdom
05 Oct 2017
04 Nov 2017
Contract Type
Full Time
With safety concerns becoming increasingly common among doctors and patients, having robust and accurate data helps us gain the trust of our customers. Our Safety and Pharmacovigilance service has been one of our core offerings since 1992. We have a global team of experts who can support our customers across all phases of clinical trials and post marketing surveillance ensuring timely collection, analysis and reporting of safety data according to each company's regulations. This is an exciting opportunity to join our QPPV Office and act as Safety Quality and Compliance Specialist Pharmacovigilance System File (PSMF) Specialist in a global CRO providing Post-Marketing Pharmacovigilance solutions tailored to the pharmaceutical industry. This position can be based in one of the following countries: Denmark, Sweden, Germany, France, Spain or Poland. A summary of duties you will be involved in as Safety Quality and Compliance, PSMF Specialist: 1. Assist, support and provide technical support and co-ordination to the EU QPPV Director, Safety & PV Post marketing for the creation, registering and maintenance of relevant clients Pharmacovigilance System Master File(s). 2. Assist the EU QPPV to ensure delivery and updates to the client's PSMF. 3. Assist the QPPV Office staff in relation to various tasks, meetings and deliverables in relation to QPPV Office documentation. 4. Interact with clients to collate information for PSMF. 5. Prepare and develop safety data exchange agreements (SDEAs). 6. Participate in the generation and maintenance of quality documents (Policies, SOPs, Charters, Agreements, etc.). The intent is that the specialist will be assigned leadership of specific processes in the QPPV office related to work tasks. 7. Support and guide relevant safety team members to deliver relevant safety objectives in relation to the PSMF including but not limited to safety training, inspection readiness and PV system set-up. 8. In collaboration with EU QPPV and PV QA/CQ - be involved in drafting, update and authoring of PV corrective and preventative action plans to ensure reflection of open findings in the PSMF. 9. Provide mentoring and training of global and local PV staff to ensure knowledge sharing and PV qualifications. Act as go-to point of contact for local Safety officers in allocated projects when needed. Qualifications To succeed in this role you will need the following skills/experience: BA/BS in life sciences or Registered Nurse (RN). Extensive Pharmacovigilance and/or regulatory experience within the post marketing area. Exposure to and knowledge of PSMF and QPPV related activities. Very structured and detail-oriented with an excellent ability to keep the overview of complex projects. Excellent communication skills including written and verbal communication. Proficiency in Microsoft Office Suite, web-based systems, voicemail, Email and Internet are necessary; basic MS Project skills are preferred. Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. Ability to perform several tasks simultaneously to meet deadlines preferred. What happens next: If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
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