Senior Pharmacovigilance Officer

Posted:28.02.17
Location:France
Salary:Highly Competitive
Reference No:DS.DM.11091
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ProClinical is working with a Small Pharmaceutical company based in Paris, who is looking for experienced Pharmacovigilance individuals to join their team as a Senior Pharmacovigilance Officer.

Job Role and Requirements:

  • Ensure the drafting of the pharmacovigilance part of MA dossiers and regulatory dossiers (IND, NDA, Scientific Advice, ...)
  • Ensure that the pharmacovigilance system meets international regulatory obligations
  • Assess the benefits / risks of products in all indications
  • Develop DSURs, PSURs, PDERs, local syntheses and pharmacovigilance reports
  • Prepare, implement and monitor the application of pharmacovigilance procedures
  • Inform and advise healthcare professionals on product tolerance
  • Perform national and international regulatory and scientific monitoring
  • Record the reported cases and the set of pharmacovigilance information in the database
  • Analyze reported cases (severity, imputability, expected or unintended character) in the investigator if necessary

Job Requirements:

  • The successful candidate must be at least a Pharmacist and have a minimum of 3 years' experience in Pharmacovigilance
  • Skills: Signal Detection, Risk Management, PV Systems and Case Processing.
  • You must have an in-depth knowledge of French Health Regulations and international experience would be an advantage.

To Apply

Please click the Apply button and write a short note explaining why you are suitable for the role. Alternatively, to learn more about this career opportunity, please reach out to Divya Mistry directly on +44 203 8718 091 or send your CV to d.mistry@proclinical.com. A full job description will be 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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