Conduct case triage, data entry, MedDRA coding and Quality checks where needed
Assess seriousness, expectedness, and regulatory reporting requirements in line with EU GVP.
Ensure timely submission of ICSRs
Assist the QPPV with routine oversight of the PV system, including compliance metrics and quality checks.
Contribute to the maintenance and periodic update of the Pharmacovigilance System Master File (PSMF).
Support the QPPV in responding to regulatory queries, inspections, and audits.
Help ensure that QPPV responsibilities are met across vendors, partners, and affiliates
Requirements
A University degree in a Life-sciences discipline is required
Must have demonstrated experience working in Pharmacovigilance in Case processing
Ideally skilled in supporting QPPV activities
Must demonstrate strong communication skills and have thorough knowledge of the regulations within the EU
Fluency in English and ideally Swedish (or another EU language) is a must
Can work hybrid based out of Lund
Can perform the project to the desired requirements set out in the job description
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
Benefits
Health insuranceRemote work optionsEquity / stock options
Additional Information
For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
Position overview
ProPharma is currently supporting a global Life-sciences brand as their Pharmacovigilance department requires support for Case Processing and QPPV activities with in the EU. This position is offered as a one year project (Fixed term or freelance/Contract); it will offer 1.0 FTR (40 hours per week) and is to commence immediately. The role is required Hybrid working based out of Lund throughout the project and fluency in English and ideally Swedish (or another EU language) is a must.
Propharmagroup · Sweden