Arbetsbeskrivning

At Ribocure, we are driven by science and innovation, with a mission to establish a world-leading company in RNA research and development, ultimately making a positive impact on patients worldwide. 

The PV Manager position is part of the Pharmacovigilance group at Ribocure and our parent company, Ribo in China, while reporting to the Head of Clinical Operations at Ribocure. The role will work closely with the global PV team to ensure seamless collaboration and alignment across both companies.

In this role, you will oversee pharmacovigilance activities related to Ribocure’s and Ribo’s clinical programs, ensuring compliance with global regulatory requirements, high-quality safety data collection, and timely reporting. You will collaborate closely with cross-functional teams to maintain a robust safety surveillance system across the product lifecycle.

We are seeking a candidate with proven experience in pharmacovigilance and drug safety within the pharmaceutical or biotech industry, strong regulatory and operational expertise, and the ability to drive high-quality safety activities in a dynamic and fast-paced environment.

Key responsibilities:

• Developing, maintaining, and executing Clinical Trial Safety Management Plans and related safety documents.
• Managing the collection, processing, assessment, and submission of Individual Case Safety Reports (ICSRs) in compliance with applicable regulations and timelines.
• Preparing, reviewing, and submitting aggregate safety reports (e.g., DSURs, annual safety reports) in collaboration with global PV colleagues.
• Compiling and communicating safety information to internal stakeholders, Clinical Operations, and external partners to support ongoing clinical trials.
• Contributing to signal detection, evaluation, and risk management activities to ensure continuous monitoring of product safety profiles.
• Supporting clinical development programs and regulatory submissions, including the preparation and review of IND and other regulatory application documents.
• Establishing, maintaining, and updating PV SOPs to align with evolving regulatory and company requirements.
• Leading and supporting PV-related training for project teams and department staff to ensure awareness and compliance with safety processes.

Requirements:

• Strong knowledge of pharmacovigilance regulations and guidelines across major regions, including EU, China and the U. S.
• Solid understanding of drug development processes and pharmacovigilance activities throughout clinical trial phases.
• Hands-on experience with one or more global or regional pharmacovigilance databases and safety systems.
• Excellent communication and collaboration skills, with the ability to work effectively in a cross-functional and global team environment.
• Proactive approach to learning, with strong analytical and problem-solving abilities.
• Attention to detail and strong organizational skills, ensuring accuracy and compliance in safety data management.

We offer more than a job – we offer a mission. You’ll be part of a tight-knit, friendly team working on real challenges with real potential. Your ideas matter. Your work matters. And your growth matters to us.

We encourage you to submit your CV and cover letter promptly, as applications will be reviewed on an ongoing basis. Final application deadline: 14th of December.

Hiring manager: Rebeckha Magnusson, Head of Clinical Operations & QA