PV Associate

Posted 6 Days Ago
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Hiring Remotely in Warsaw, Warszawa, Masovian
Remote
1-3 Years Experience
Biotech • Pharmaceutical
The Role
The PV Associate at PrimeVigilance will work as part of a project team, processing Individual Case Safety Reports in compliance with regulations and client requirements. They should have advanced English and German skills, a life science background, and strong attention to detail.
Summary Generated by Built In

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 all 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 device. 

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we 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. 

Come and join us in this exciting journey to make a positive impact in patient’s lives. 

Job Description

The PV Associate should be a Life science / bio medical background graduate or have other healthcare related degree qualification (chemistry, biology, biotechnology, veterinary science etc.) This is an opportunity for new graduates to start and develop their career within drug safety. The PV Associate will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance.

If you join PrimeVigilance, you can expect to work with teams of different sizes, from small clinical trial, to large, generic post-marketing teams. We are always looking for proactive, capable and motivated individuals who aim to surpass any target set in front of them 

Responsibilities: 

  • Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. 
  • Reconciliation activities for all types of received reports 
  • Works under supervision and mentoring of more experienced colleague 

Qualifications

Requirements: 

  • Advanced English and German skills, both verbal and written, at least B2 
  • Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science), previous experience is not required. 
  • People who are excited to learn and contribute to patient safety 
  • Time and issue management, delegation, organization and multitasking skills with good attention to detail 
  • Strong interpersonal and communication skills 

Additional Information

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 on improving the lives of those around us. 

Our Offer

  • Competitive salary
  • Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
  • Multicultural environment, English as a company language
  • Strong emphasis on personal and professional growth
  • Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals, but also prestigious trainings/seminars taking place abroad
  • Friendly working environment with several social events per year


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. 

Top Skills

English,German
The Company
HQ: Raleigh, NC
535 Employees
On-site Workplace
Year Founded: 1997

What We Do

Founded in 1997, Ergomed is a global provider of high-quality services to the biopharmaceutical industry, spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, and Ergomed Clinical Research, a complete, global Phase I-IV clinical development and trial management services with a strong heritage in the development of drugs in rare diseases and oncology.

• 1,400+ highly qualified professionals
• Global full-service CRO
• 25+ years of experience
• Therapeutic specialization in oncology
• Strong expertise in rare disease trials
• Robust clinical safety system
• Choice of leading drug safety databases

Our key services include:
• Clinical Research Services
• Pharmacovigilance
• Medical Information
• Regulatory
• Medical Writing
• Site Management
• Study Physician Support
• Biostatistics
• Patient Study Support

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