Pharmacovigileance Manager

Highly Competitive
  1. Permanent
  2. Pharmacovigilance
  3. France
Paris, France
Posting date: 08 Feb 2021

A vacancy has arisen for a Pharmacovigilance Manager to join a pharmaceutical company in France, in this role you will be expected to oversee all pharmacovigilance activities

Job Requirements

  • Prepare the pharmacovigilance part of Marketing Authorization and regulatory dossiers (IND, NDA, Scientific Advice, ...)
  • Lead the preparation of the Investigator Brochure, IDSURs, PSURs, PDERs, local synthesis and pharmacovigilance reports
  • Assess the risk / benefit of the products in all indications
  • Implement and monitor the set-up of pharmacovigilance procedures
  • Ensure that the pharmacovigilance system can meet international standards
  • Inform and advise health professionals on product safety
  • Conduct a national and international regulatory and scientific monitoring
  • Save the reported cases and all pharmacovigilance information in the database
  • Analyse the reported cases with the investigator if necessary
  • Manage the Pharmacovigilance team

Skills and Requirements

  • PharmaD or MedicalD - A specialization in oncology and / or autoimmune diseases would be a plus
  • Significant and successful experience in pharmacovigilance, with a minimum of 5 years in a global position
  • Writing experience regarding product safety for study documents and regulatory dossiers
  • Expertise of the French and international regulatory environment regarding pharmacovigilance
  • Fluent in French and English

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.