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Pharmacovigilance Project Manager

About the job

Pharmexon Consulting is a dynamic consultancy company for the pharmaceutical industry, specialized in offering full support for registration and approval of medicines in Europe. Our client base is worldwide. We combine the strength of our expertise, experience and creative strategies to support the pharmaceutical companies to deliver life changing therapies faster to the market. Visit our website: www.pharmexon.com.

PHARMACOVIGILANCE MANAGER

The position reports to Senior Pharmacovigilance Manager,

Hybrid role – office in the city centre of Prague,

Freelance contract – CZ trade license (IČO),

Motivating remuneration / Company benefits.

Key Responsibilities

  • Receives project announcements and incorporates them into the project management software.
  • ICSR and AE management with notification through Eudravigilance and CIOMS form to the Case assessment and processing.
  • Writing and Submission of PSURs / PBRERs and RMPs XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) management.
  • Signal Detection and Management
  • Manages projects throughout their lifecycle for the possibility of a smooth handover
  • Ensures that project is invoiced at the appropriate milestones.
  • Archives projects when finished and maintains an appropriate level of knowledge regarding ongoing projects
  • Overviews project goals and ensure project goals are achievable
  • Procure materials and other items necessary for completing project goals.
  • Review project implementation and gather data on project execution.
  • Maintains up-to-date project records and follows internal procedures to ensure proper document filing
  • Reviews internal procedures according to practical experience and data and proposes changes to maintain up-to-date processes
  • Makes use of the help of administrative support and delegates tasks.
  • Evaluates which tasks can be delegated and which need direct input
  • Checks the delegated work to make sure it is delivered on time and in good quality
  • Helps train colleagues on specific projects if required.
  • Shares expertise with the team when new members join as well as if pertinent information for pharmacovigilance
  • Provides assistance and knowledge to the team members to ensure smooth completion of projects
  • Communicates with suppliers to ensure timely delivery of documents and deliverables for projects
  • Communicates with other team members to provide insight into workload of suppliers
  • Provides feedback on work with suppliers to evaluate the quality of their services.
  • Communicates with clients (internal, external) to make sure their needs are met.
  • Requests pertinent documentation from client and provides advice within the scope of the project
  • Maintains a professional relationship with clients via email and potentially via meetings and calls as needed

Qualifications nad Skills

  • University graduate (Pharmacy, Veterinary Medicine, Biology)
  • At least 2 years of practical experience in Pharmacovigilance area
  • Fluency in both written and spoken English
  • A good understanding of medical concepts and a confident user of English medical terminology
  • Adaptability to routine activities but also to finding fast answers and solutions to unexpected situations.
  • Willingness to quickly learn and develop in a multicultural team of highly skilled professional.
  • Good computer skills (Office-Excel, Word, PowerPoint; Outlook).
  • Independent problem solving and decision making skills.
  • Process oriented and critical thinking.
  • Excellent attention to detail and organizational skills.
  • Able to multitask.
  • Task oriented approach
  • Willing to do work-related reading outside of work.
  • Hard working, self-reliant and responsible person

Preferred Qualifications

    Benefits

    • Attractive remuneration package,
    • 25 days of paid leave days, 5 sick days
    • Contribution for meal voucher
    • Multisport Card
    • Contractor/ Freelancer based in CZ
    • Hybrid work mode from the office in Prague
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    Job information
    • Hybrid
    • Pharmacovigilance Project Manager
    • schedule-calendar

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    Important

    Pharmexon Consulting s.r.o.

    • Štěpánská 65
      110 00 Prague 1
      Czechia
    • File number: C 260981
      Held at the Municipal Court in Prague
    • Company number: 05267846
    • If you have any questions about any of our products or if you wish to report an adverse event, please contact us on: safety@pharmexon.com
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