PV Officer
hace 3 semanas
PrimeVigilance is a specialized mid-size 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.
We provide first-class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and have become one of the global leaders in our field. We cover all therapy areas, including medical devices.
We invest in our staff by providing an excellent training and development platform. We value employee experience, well-being, and mental health, and acknowledge that a healthy work-life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Job DescriptionAt PrimeVigilance, Pharmacovigilance Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability.
As a Pharmacovigilance Officer, you will work with teams of different sizes, from small clinical trials to large, generic post-marketing teams. We are looking for proactive, capable, and motivated individuals who aim to surpass any target set in front of them.
The ideal candidate will have a Life science or biomedical background graduate or have other healthcare-related degree qualifications (chemistry, biology, biotechnology, veterinary science, etc.) and have demonstrated experience in case processing.
Responsibilities include:
- 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 in accordance with client-specific requirements and timelines.
- 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 more junior employees within the department, including procedure optimization and development.
To be successful in this role, you will need:
- A Life science or biomedical background – healthcare-related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing.
- Demonstrated case processing experience.
- ARGUS experience preferred.
- 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.
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. Why? Because our people are our greatest strength, leading to our continued success 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, and if you feel they resonate with you, then PrimeVigilance could be a great company to join.
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
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