Pharmcovigilance Case processing & Quality Product Complaint Specialist

ProPharma Group; Stockholms kommun; Hybrid; SEK 480,000 - 600,000; Full time

Job summary

ProPharma Group in Sweden is seeking support for pharmacovigilance case processing and QA product complaints activities. This role is hybrid, with two days on-site at our Malmö client site, starting as soon as possible for at least six months.

The successful candidate will review adverse event reports, perform MedDRA coding, assess seriousness and regulatory reporting requirements under EU GVP, ensure timely ICSR submissions, and collaborate with stakeholders across the organization to maintain

Qualifications

• Experience in Pharmacovigilance case processing or QA product quality complaints.
• Fluent in English; Swedish or Danish is a plus.
• Strong communication skills and attention to detail.
• Ability to follow procedures and regulatory guidelines.

Responsibilities

• Review adverse event 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 internal procedures and regulatory standards.
• Maintain an accurate record of data to ensure compliance with guidelines.
• Monitor complaint timelines.
• Collaborate with key internal stakeholders across the organization.
• Provide overall support to Pharmacovigilance and Quality Assurance teams.

Skills

Pharmacovigilance

Quality assurance

Communication skills

Attention to detail

English fluency

Swedish/Danish (optional)

Education

University degree in Life sciences

Job description

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 overviewProPharma 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.ResponsibilitiesReview adverse even reports and quality complaints and ensure data entry is correctly achieved within the databaseConduct case triage, MedDRA coding and Quality checks where neededAssess seriousness, expectedness, and regulatory reporting requirements in line with EU GVP.Ensure timely submission of ICSRs when neededEnsure product complaints are documented to all internal procedures and regulatory standardsMaintain an accurate record of the data to ensure it is in compliance with all necessary guidelinesMonitor complaint timelinesCollaborate with key internal stakeholders across the organizationOverall support to Pharmacovigilance and Quality Assurance teams where necessaryQualificationsA University degree in a Life-sciences discipline is requiredCan demonstrate experience working within Pharmacovigilance case processing or QA product quality complaintsFluent in English and ideally Swedish/DanishExcellent communication skillsStrong eye for detail and following proceduresCan perform the job role described in the position overview#LI-DNIWe 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.***