Pv Officer

hace 3 semanas

Madrid, España Ergomed A tiempo completo

Company Description We are PrimeVigilance (part of Ergomed Group), a specialised 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.
PrimeVigilance provides first-class support to our small to large pharmaceutical and biotechnology partners, maintaining long-lasting relationships and has become one of the global leaders in its field.
We cover all therapy areas including medical devices.
We love investing in our staff by providing an excellent training and development platform.
We value employee experience, well-being, and mental health, acknowledging that a healthy work-life balance is a critical factor for employee satisfaction and nurtures an environment for high-quality client service.
Come and join us in this exciting journey to make a positive impact in patients' lives.
Job Description At PrimeVigilance, PV Officers are independent case processing team members who are expected to manage a variety of case processing services with full accountability.
If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trials to large generic post-marketing teams.
We are always looking for proactive, capable, and motivated individuals who aim to surpass any targets set in front of them.
The PV Officer should have a life science/bio medical background graduate or a healthcare-related degree qualification (chemistry, biology, biotechnology, veterinary science, etc.)
and demonstrated experience in case processing.
The PV Officer will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.
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 client-specific requirements and timelines.
As a key member, there is an expectation to effectively 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 more junior employees within the department, including procedure optimization and development.
Qualifications Life science/bio medical background – healthcare-related degree (chemistry, biology, biotechnology, veterinary science) and 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, 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 We look forward to welcoming your application.
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