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QPPV

  1. Antwerp
Belgium
  1. Permanent
Competitive
  1. Drug Safety / Pharmacovigilance
03-07-2023
31472

This vacancy has now expired

QPPV – Life Sciences – Permanent – Belgium 

Our client, a prominent consulting and solutions firm specialising in risk management and compliance services for the pharmaceutical industry, has been driving advancements in the development-to-market process with efficiency and innovation since 2008.

They offer comprehensive global services that cover the entire product life cycle, including Clinical, post-submission Regulatory Affairs, Pharmacovigilance, Quality Assurance, Auditing, and cutting-edge automation solutions.


QPPV Responsibilities:
  • Executes project tasks primarily specific to the unit, but also cross-functional, including without limitation Global ICSR processing, Global Literature monitoring.
  • Signal Management and Benefit Risk Management activities, Medicinal Product Management (XEVMPD), Local project management, Local literature monitoring management, Local ICSR management, LPPV/LSO management.
  • Monthly reporting and compliance monitoring, Regulatory Intelligence, preparation and QC of pre-marketing and post-marketing aggregate reports (e.g. PSUR, DSUR, PBRER, PADER, etc.) Risk Management Plans(RMP), Study protocols , product documentation(SmPC, IB), Pharmacovigilance system master file (PSMF), performing the EU QPPV and deputy EUQPPV roles.
  • Oversight over the assigned Pharmacovigilance system(s), Management of project related PV contracts (PV service agreements, Safety data exchange agreements), Pharmacovigilance system master file management, EU QPPV EudraVigilance related activities.
  • Executes other project specific task as and if required.
  • Assign PV unit team members (PV specialist, PV associates, PV assistant) with project tasks and approach other unit team leads for resource allocation as and if required.
  • Act as escalation point for project team members (PV specialist, PV associates) for technical project issues, technical tasks and process issues or client complaints in relation to the project or technical work performed.
  • Escalate technical project issues further to the concerned unit team leads.
  • Involvement together with other team members in the scoping phase when and if required.
  • Support the PV Business Manager in proposal preparation as and if required.
  • Improvement of processes within the assigned Unit, ensuring a smooth run of the project, tasks and processes; ability to capture all running projects, tasks and processes within the unit and their relations to other units within the PV department.
  • Oversee the work performed by the project team members (PV specialists, PV associates, PV assistants) and ensure a high standard and quality of delivered work.

About you:
  • Bachelor’s degree or graduate in pharmaceutical sciences or related fields – medicine, pharmacy, life sciences – advance degree (e.g. masters)
  • Preferable minimum of 4 years of experience working in a medical or safety department with demonstrable expert knowledge of medical terminology
  • Residency in Belgium
Are you a good fit for this job title? Get in touch with us today.



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