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Pharmacovigilance & Risk Management Manager

Location:Poland - Poland
Salary:Highly Competitive
Reference No:DS.KH.10405i

Our client, a global leading pharmaceutical company, is seeking a Pharmacovigilance and Risk Management Manager to join their team in various locations across Europe. These opportunities are largely home-based and are on a permanent basis. 

Job Role:

  • To participate in Global Pharmacovigilance & Risk Management team activities
  • To assist in global signal detection and risk management activities

Job Responsibilities:

  • Conduct signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked. Identify potential signals and validate. 
  • Contribute to analyses in external databases using data mining methods for detection and evaluation of safety signals. Assist in aggregate safety data review and preparation of signal assessment reports.
  • Coordinate/co-author the finalization of regulatory documents such as RMPs/REMS, PSURs, DSURs and Ad hoc requests from regulatory agencies
  • Provide strategic and proactive safety inputs into clinical development plans including protocols, CSRs, IB and informed consent.
  • Maintain pharmacovigilance expertise, understanding of international safety regulations and guidelines.
  • Develops, communicates, and implement best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects.
  • Liaison with internal stakeholders, including members of Clinical, Medical Affairs, Data Management, Statistics, and Regulatory Affairs, in a matrix environment as needed for specific project needs / plans.

Education, Skills and Experience:

  • Advanced degree in health care; Physician's Degree strongly preferred
  • 0-1 years of clinical experience and 1-2 years of relevant pharmacovigilance work experience
  • Good standard of literacy and written communication
  • Good computer skills, including Excel, Word and Powerpoint
  • Broad regulatory affairs experience covering PV and medical devices (to include comprehensive knowledge of the GVP Modules and ISO 13485) and the full range of submissions
  • Experienced in dealing with local regulatory agencies
  • Good understanding of business processes
  • Knowledge of domestic and international post-marketing regulations preferred
  • Clinical safety and Pharmacovigilance regulations and guidelines
  • Knowledge of scientific terms and medical terminology
  • Thorough knowledge of pharmacovigilance, signal detection and risk management
  • Knowledge of statistical software and use of drug safety database, preferably ARISg, AgSignals

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 4400 636 or upload your CV on our website
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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