Freelance/Contract - Pharmacovigilance Specialist, Case Processing & QPPV Support

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.

Responsibilities

• Perform end‑to‑end processing of ICSRs

• 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

Qualifications

• 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

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***