Patient safety scientist to AstraZeneca

Modis Life Science is now looking for a senior scientist for Patient Safety to AstraZeneca in Gothenburg.This is a consultancy position approximately 50% of full-time. Starting date, middle of september until end of year. If you find the job description interesting, please send your application ASAP, deadline August 26th.

Core activities:
• Support execution of EU QPPV responsibilities for Medicinal Products approved in the EU as delegated by the EU QPPV
• Support Management of EU QPPV ad hoc non-product related responsibilities as delegated by the EU QPPV

The position reports to the EU QPPV & Head Pharmacovigilance Excellence

Typical Accountabilities

Delegated co-deputy QPPV accountabilities and responsibilities for specified Medicinal Products Authorised or with a Marketing Authorisation Application (MAA) in the EU:
• Support ensuring the necessary quality, including the correctness and completeness, of Pharmacovigilance (PV) data submitted to the European Medical Agency (EMA), the Pharmacovigilance Risk Assessment Committee (PRAC) and EU national competent authorities.
• Aware of strategic direction for EU Market Authorisation Applications (MAAs) and substantial EU Life Cycle Management (LCM) submissions in relation to own tasks
• Aware of any conditions or obligations adopted as part of EU marketing authorizations and other commitments relating to safety or the safe use of the products in relation to own tasks
• Oversight of the safety profile of Medicinal Products in relation to own tasks
• Oversight of the risk profile of Medicinal Products including associated risk minimisation measures in relation to own tasks
• Review, endorse and sign-off of (EU) Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation (PBRERs) and license renewal Addendum to Clinical Overview (ACOs) as assigned
• Review of Post-Authorisation Safety Studies (PASS) protocols for studies conducted in the EU or pursuant to a RMP agreed in the EU, ready for QPPV sign-off. Aware of the results of PASS and provide input to the interpretation of such results.
• Support the preparation of, review and endorse responses to ad hoc (non-MAA-related) requests, queries and questions from EU and other Health Authorities (HAs)
• Support the preparation of, review and endorse Health Hazard Evaluations (HHEs) regarding manufacturing quality issues with potential impact on patients
• Participate in QC checks of case seriousness assessments
• Regularly, and as needed, keep the EU QPPV informed about (above-mentioned and other) activities, deliverables and issues in scope of the delegation

Delegated co-Deputy QPPV ad hoc non-product related responsibilities:
Could include, but not locked or limited to:
• Input to and review of elements of the Pharmacovigilance System Master File (PSMF)
• Input to, review of new and updated Procedural Documents
• Participation in ad hoc assigned QPPV Office Gatekeeper Operating Model tasks
• Support continuous improvement projects in scope of the QPPV function to improve processes within Patient Safety
• Support the EU QPPV in licensing partner audits and local HA inspections
• Regularly, and as needed, keep the EU QPPV informed about (above-mentioned and other) relevant activities, deliverables and issues in scope of the delegation

General accountabilities:
• Share best practice in areas of PV, as relevant in relation to own tasks
• Upon request participate and/or support activities for GVP audits/inspections

Essential qualifications:
• Medical degree
• Extensive expert experience in Patient Safety in the pharmaceutical industry
• Detailed knowledge of relevant PV legislation
• Insight in current developments in the pharmaceutical industry
• Excellent communication skills
• Project management experience

Desirable
• PhD in scientific discipline
• Master´s degree or equivalent qualification in relevant life science discipline
• Expert reputation within the business and industry
• Extensive knowledge of the latest technical and regulatory expectations in the PV area