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PV Officer

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  • Job
    Full-time
    Junior, Mid & Senior Level
  • Research & Development
    Healthcare
  • Germany, +11
    Remote

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 do I need to apply for the PV Officer position?

You need a life science or biomedical background, such as a degree in chemistry, biology, biotechnology, or veterinary science, along with demonstrated experience in pharmacovigilance case processing.

Is experience with ARGUS essential for this role?

While ARGUS experience is preferred, it is not explicitly stated as essential for the role.

What are the key responsibilities of a PV Officer?

The key responsibilities include processing Individual Case Safety Reports, managing SAE/SUSAR submissions, preparing database outputs for periodic reporting, and mentoring newer employees.

How long does it take to reach a high level of performance after joining?

PV Officers are expected to reach and maintain a high level of performance within 3 months of being assigned to an ICSR team after completing onboarding.

What languages do I need to be proficient in for this position?

You need to have advanced English skills, both verbal and written, at least at the C1 level.

Will there be training and development opportunities?

Yes, PrimeVigilance offers internal training and career development opportunities, emphasizing personal and professional growth.

What is the work environment like at PrimeVigilance?

The work environment is described as friendly and supportive, promoting collaboration and a human-centric approach.

How does PrimeVigilance prioritize diversity and inclusion?

PrimeVigilance creates an equal opportunities workplace, emphasizing a human-centric environment where individuals from diverse backgrounds can contribute and grow.

Are there opportunities for mentoring in this role?

Yes, PV Officers are expected to mentor and train new and junior employees within the department.

What values are important to PrimeVigilance?

PrimeVigilance values quality, integrity and trust, drive and passion, agility and responsiveness, belonging, and collaborative partnerships.

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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