Overview

Join to apply for the Junior PV Officer/PV Officer role at PrimeVigilance.

We are PrimeVigilance (part of Ergomed Group), a specialised pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to pharmaceutical and biotechnology partners, maintaining long lasting relationships and serving a wide range of therapy areas including medical devices. We invest in staff through training and development, value employee well-being and a healthy work-life balance, and aim to make a positive impact in patient lives.

Job location: Warsaw, Mazowieckie, Poland.

Job Description

At PrimeVigilance, PV Officers are independent case processing team members who manage a variety of case processing services with full accountability. You will work with teams of different sizes, from small clinical trials to large post-marketing teams. We seek proactive, capable and motivated individuals who aim to surpass targets. The PV Officer should have a Life science / biomedical background or other healthcare-related degree and demonstrated experience in case processing. The PV Officer will work as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.

Responsibilities

• Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and client-specific requirements and timelines. As a key member, cover all steps of a workflow cycle, except Medical Review.
• Independent SAE/SUSAR management (submissions, unblinding, clinical trial reconciliations)
• Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.)
• Mentoring and training of new and junior employees within the department, including procedure optimization and development

Qualifications

• Life science / biomedical background – healthcare-related degree (chemistry, biology, biotechnology, veterinary science) with demonstrated experience in pharmacovigilance case processing
• Demonstrated case processing experience
• Time and issue management, delegation, organization and multitasking skills with good attention to detail
• Strong interpersonal and communication skills
• Advanced English skills, both verbal and written, at least C1

Additional Information

Why PrimeVigilance? We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human-first approach. Our people are our greatest strength in improving the lives of those around us.

We Offer

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, Collaborative Partnerships. We look forward to welcoming your application.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Other, Information Technology, and Management
• Industries: Pharmaceutical Manufacturing

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