Pharmacovigilance Manager

ABOUT THE COMPANY

Pharmexon Consulting is a dynamic Consultancy company for the pharmaceutical industry. It specializes in offering full support for companies to develop, register, and maintain medicines on the market. Our clients are based worldwide and as we are rapidly growing, we seek to find people who would complement our teams and support us and also maintain and develop the current client base. The company is now facing an exciting time with further expansion of the business, leading to a number of opportunities arising to join our team. You would be based in our office in center of Prague (CR), working within an excellent environment in a friendly, professional team who will train and support you in order to meet the highest level of quality and client expectations.

SKILLS REQUIRED

  • University graduate (Pharmacy, Veterinary Medicine, Biology)
  • Fluency in both written and spoken English.
  • A good understanding of medical concepts and a confident user of English medical terminology.
  • Easiness to communicate in English with foreign colleagues and business partners
  • 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)
  • Practical experience in Pharmacovigilance is an advantage
  • Advanced knowledge of English
  • Advanced knowledge of MS Word and MS Excel
  • 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

KEY RESPONSIBILITIES

  • Report directly to EU QPPV
  • ICSRand AE management with notification through Eudravigilance and CIOMS form to the
  • Cas
  • Writing and Submission of PSURs / PBRERs and RMPs
  • XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) management
  • SOP, SDEA, and PSMF creation and review
  • Signal Detection and Management
  • Cooperation within the pharmacovigilance team
  • Extensive Training
  • Auditing

WE OFFER:

  • An exciting and challenging job in an innovative, flexible, and growing company
  • A team of young, hard-working, open-minded and friendly colleagues
  • Initiation and trainings in Pharmacovigilance field reflecting the latest European requirements

COMMERCIAL OFFER

  • Salary is negotiable and commensurate with experience.
  • Flexible working hours.
  • Meal vouchers / Contribution for meal