Company

KCR

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Pharmacovigilance Specialist

Publication

2018-11-30

Company description

KCR is a contract research organization providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries.
The company supports clients with full-service capabilities across three main services: Trial Execution (TE), Functional Service Provision (FS) and Trial Execution Consulting (TC) over a broad range of therapeutic areas. 
KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe with hubs located in Boston, U.S., Berlin, Germany, Warsaw, Poland and Kiev, Ukraine. KCR’s geographical locations allow for optimized delivery of trial execution strategies to develop life-changing therapies. For more information visit www.kcrcro.com.
KCR: We see human behind every number
A leading Clinical Research Organisation (CRO), with over 20 years of presence on the international market, operating across 27 countries is seeking to employ Pharmacovigilance Specialist
The new incumbent shall take full accountability for international project and study program delivery on time, with quality and within planned budget.
This is a permanent position based in one of the company’s Operational Hubs in Warsaw (US)
.
Location: Warsaw (office-based)

The duties associated with the role include:
 
  • Registering and handling incoming safety reports concerning investigated products derived from clinical studies
  • Reviewing incoming safety reports for accuracy, completeness and potential safety issues
  • Maintaining of safety database for specific projects under supervision
  • Participating in preparation of documentation and coordinating submission process of periodic safety reports
  • Communicating with local Regulatory Authorities, IRBs or Ethics Committee
  • Contributing to overall compliance with project and departmental goals and objectives
Requirements:
  • University degree (life science preferrer), or certification in a related allied health profession from an appropriately accredited institution (nursing, medical or ladoratory technology)
  • Previous pharmacovigilance experience/safety area (at least 2 years)
  • Very good knowledge of ICH GCP, ICH/EMA/FDA and other guidliness applicable fo PV area
  • Very good command of English
  • Analytical and problem-solving skills
  • Focused on details
  • Excelent work organization and ability to work under time pressure
At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits
that comply with national regulations and provide the coverage that best meets employee needs.
To show that you are appreciated in our team, while working at KCR you will be provided with: 
  •  3-step onboarding process to enable you fast takeover of duties
  •  Peer Buddy Mentor who will introduce you to the organization
  •  Friendly office space, coffee, tea and sweets
  •  Flexible, remote working options
  •  Time off – additional days of holidays for birthday, leaves of absence
  •  Loyalty bonus for long term cooperation
  •  Employee referral program
  •  Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
  •  Open culture based on our values: knowledge, customer focus, accountability, commitment, tenacity and determination to succeed
  •  Mentoring and training programs related with clinical trials, therapeutic areas, soft skills development
If you wish to apply, please submit your CV using the button below.