PV Officer (Senior Level Position)
Location: Madrid, Spain (Remote work possible)
Full-time
Department: ICSR Management
Company: PrimeVigilance (Part of Ergomed Group)
Company Overview:
PrimeVigilance is a specialized pharmacovigilance service provider, part of the Ergomed Group, established in 2008. We are proud of our organic growth year over year, with teams spanning across Europe, North America, and Asia. We offer support to pharmaceutical and biotechnology companies, providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. We cover all therapy areas, including medical devices.
We are passionate about our employees’ professional growth and well-being. By offering excellent training and development platforms and prioritizing work-life balance, we foster an environment that ensures high-quality service for our clients.
Job Overview:
As a PV Officer, you will manage the full cycle of case processing activities within the pharmacovigilance function, ensuring compliance with regulations and client requirements. You will be expected to handle both post-marketing and clinical trial reports and work with diverse teams on various projects. This is an exciting opportunity for those with a background in life sciences and prior experience in pharmacovigilance case processing.
Key Responsibilities:
Case Processing:
Process Individual Case Safety Reports (ICSRs) from various sources (post-marketing, clinical trials, device, and combination products) in compliance with applicable regulations and PrimeVigilance procedures.
Manage all steps of the case processing workflow, excluding the medical review.
Independent Management:
Oversee the submission and unblinding process, including SAE/SUSAR management for clinical trials and reconciliations.
Reporting:
Prepare database outputs for periodic safety reporting such as PBRER, DSUR, and PADER.
Team Support and Development:
Mentor and train junior team members, providing guidance and supporting them in optimizing and developing department procedures.
Qualifications:
Educational Background:
Degree in Life Sciences or related healthcare fields (e.g., Chemistry, Biology, Biotechnology, Veterinary Science).
Experience:
Several years of demonstrated experience in pharmacovigilance case processing.
Skills:
Strong organizational, time management, and multitasking abilities.
High attention to detail and effective issue management.
Excellent communication skills, both written and verbal (English at C1 level or higher).
Why Join PrimeVigilance?
At PrimeVigilance, we prioritize creating a diverse, inclusive, and human-centric workplace. We believe that success comes from working together with a focus on personal and professional growth. We offer:
Internal training and career development opportunities.
A supportive and friendly working environment.
The opportunity to collaborate with colleagues worldwide, with English as the common language.
If our core values of Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships resonate with you, we encourage you to apply and join us in our mission to improve patient safety and make a difference in people’s lives.
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