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PV Officer

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  • Job
    Full-time
    Junior & Mid Level
  • Science
    Healthcare
  • Madrid

Requirements

  • - Life science / bio medical 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

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 in accordance with 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

FAQs

What qualifications are required for the PV Officer position?

A life science or biomedical background degree (such as chemistry, biology, biotechnology, or veterinary science) and demonstrated experience in pharmacovigilance case processing are required.

Is prior experience in pharmacovigilance necessary?

Yes, demonstrated case processing experience in pharmacovigilance is essential for this role.

What software experience is preferred for this position?

Experience with ARGUS is preferred for the PV Officer role.

What are the responsibilities of a PV Officer at PrimeVigilance?

Responsibilities include processing of Individual Case Safety Reports, independent SAE/SUSAR management, preparation of database outputs for periodic reporting, and mentoring/training new or junior employees.

What kind of training does PrimeVigilance offer?

PrimeVigilance provides excellent training and development opportunities to enhance personal and professional growth.

What skills are necessary for a successful PV Officer?

Strong time and issue management, delegation, organization and multitasking skills, along with good attention to detail, are necessary for success in this role.

Is knowledge of English important for this position?

Yes, advanced English skills, both verbal and written, at least at C1 level, are required for this role.

Does PrimeVigilance encourage diversity and inclusion?

Yes, PrimeVigilance prioritizes diversity, equity, and inclusion, creating an equal opportunities workplace for all employees.

What are the core values of PrimeVigilance?

The core values include Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships.

What is the company's approach to employee well-being?

PrimeVigilance values employee experience, well-being, and mental health, recognizing that a healthy work-life balance is essential for satisfaction and performance.

Bringing expertise to deliver medicines our world can trust.

Science & Healthcare
Industry
501-1000
Employees
2008
Founded Year

Mission & Purpose

PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world. These include former senior regulators and consultants with extensive industry experience, especially with marketed products.

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