Company

KCR

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Associate/Director Pharmacovigilance

City/voivodeship

Warsaw

Publication

2019-01-11

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
KCR has over 20 years of experience in the international market and operates across 27 countries. An organization has just entered new path of further development and due to intensive development of our structures, seeks to employ an Associate / Director, Pharmacovigilance. This is an opportunity to have a significant impact on the success of the Pharmacovigilance Department and the overall success of the company. This is a permanent position based in one of the company’s Operational Hubs in Warsaw (PL).
Location: Warsaw (office-based)
 
Qualifications:
  • Strong line management skills with the ability to train and mentor direct reports
  • Prior experience in providing inputs to project design, establishment and implementation of the project’s safety strategies
  • Ability to develop Safety Management Plans for the clinical trials
  • Experience working directly with sponsor clients in a Senior Manager or Associate Director level capacity as the main point of contact in terms of pharmacovigilance
  • Ability to provide PV trainings for company employees if needed
  • Ability to prepare and verify Standard Operating Procedures fulfilling all relevant law regulations and describing an appropriate and effective pharmacovigilance system
  • Ability to assists Sponsors in Development Safety Update Report writing, compilation and submission of the report to the competent authorities within the time frames declared by the pharmaceutical laws and effective regulations
  • Experience in being a PV communication point for local Competent Authority and Ethics Committee
  • Participation in bid defense preparations and conduct bid defense meetings in partnership with Business Development Department
  • In depth knowledge of applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Proven ability to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback and coaching
  • Strong understanding of modifications in local laws, US and European Directives and guidelines related to PV
  • Excellent communication and negotiation/influencing skills
  • Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and good working relationship with company personnel at all levels and with physicians and scientists from various disciplines
  • Ability to manage work schedule in accordance with priorities
  • Flexibility and willingness to work in an international environment
  • The ability to work across departments and with leadership successfully
  • Good command of any of European languages will be a plus to travel domestically and internationally approximately 20% of time in order to perform ADP responsibilities and attend bid defense meetings
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.