Pharmacovigilance Case Processing and Quality Product Complaint Specialist

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 they are looking for support for their Pharmacovigilance case processing activities and Quality Assurance product complaints efforts in Scandinavia. This role offers full time hours; it will run for at least 6 months and we have the opportunity to employ the individual or work on a business to business approach throughout the project. This role will be performed as a hybrid basis with 2 days expected on our client’s site in Malmo and it will begin ideally in November.  

Responsibilities

• Review adverse even reports and quality complaints and ensure data entry is correctly achieved within the database
• Conduct case triage, MedDRA coding and Quality checks where needed
• Assess seriousness, expectedness, and regulatory reporting requirements in line with EU GVP.
• Ensure timely submission of ICSRs when needed
• Ensure product complaints are documented to all internal procedures and regulatory standards
• Maintain an accurate record of the data to ensure it is in compliance with all necessary guidelines
• Monitor complaint timelines
• Collaborate with key internal stakeholders across the organization
• Overall support to Pharmacovigilance and Quality Assurance teams where necessary

Qualifications

• A University degree in a Life-sciences discipline is required
• Can demonstrate experience working within Pharmacovigilance case processing or QA product quality complaints
• Fluent in English and ideally Swedish/Danish
• Excellent communication skills
• Strong eye for detail and following procedures
• Can perform the job role described in the position overview

#LI-DNI

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.***