PV Assistant

Reposted 21 Days Ago
Be an Early Applicant
Tokyo, JPN
Hybrid
Entry level
Biotech • Pharmaceutical
The Role
The PV Assistant will support pharmacovigilance activities, including tracking safety messages and Individual Case Safety Reports, while managing documentation and communication tasks.
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 Assistant will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of PrimeVigilance. Previous work experience in pharmacovigilance is not required as you will receive all necessary training from us. 

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: 

  • Receiving and returning safety messages and acknowledge receipt, tracking and filing of Individual Case Safety Reports (ICSRs) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines 

  • Submitting and tracking periodic reports 

  • Maintaining the archive and preparing documents’ final lay out 

Qualifications

Requirements: 

  • Advanced English and Japanese skills, both verbal and written, at least B2/C1 level
  • Desirable administrative experience and Strong IT skills (MS Office - Excel and word)
  • A high degree of discretion dealing with confidential information 
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail 
  • Ability to work under pressure with accuracy and meet tight deadlines 
  • Good 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. 

 

Skills Required

  • Advanced English and Japanese skills, both verbal and written, at least B2/C1 level
  • Desirable administrative experience
  • Strong IT skills (MS Office - Excel and Word)
  • High degree of discretion dealing with confidential information
  • Ability to manage multiple tasks and prioritize workload
  • Ability to work under pressure with accuracy and meet tight deadlines
  • Good interpersonal and communication skills
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The Company
HQ: Raleigh, NC
535 Employees
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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