pharmalex_job_career



We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

 

Pharmacovigilance Manager


Your Job

  • Implement and administrate PV systems
  • Write and update project related Safety Management Plans/Safety Data Exchange Agreements
  • Register and maintain Eudravigilance profiles
  • Oversight of Case Management Process
  • Review and update Periodic Safety Update Reports (DSURs/PSURs/PBRERs)
  • Write and maintain Pharmacovigilance System Master Files (PSMF)
  • Lead pharmacovigilance projects and coordinate project team activities
  • Interact with agencies, when required
  • Interact with clients and ensure compliance with the project scopes and budgets
  • Contribute to the preparation of proposals
  • Manage of audits and inspections
  • Write and keep pharmacovigilance procedures up to date
  • Perform weekly regulatory surveillance
  • Ensure compliance with the internal and client quality procedures
  • Prepare content of presentations for conferences, webinars, blogs and posts

Your Profile

  •  Pharmacist
  • 5 to 8 years of professional experience in the field of vigilance
  • Knowledge of relevant legislative guidelines on vigilance
  • Distinctly strong service orientation
  • Ability to manage one or several activities with limited guidance
  • Independent approach to work, flexibility and dedication
  • Diplomacy, ability to communicate and integrate in an international and multicultural environment
  • Strong sense of responsibility, organizational skills and intrinsic motivation
  • Dutch and English language fluency, written and spoken 



If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

Agencies only by prior agreement for the specific job opportunity.