ProClinical is seeking a Head of Pharmacovigilance for a pharmaceutical company with a robust drug discovery platform which has generated new compounds ready to be launched into preclinical development. This is a permanent position to be based in Paris, France.
- 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 watch
- Record the reported cases and the set of pharmacovigilance information in the database
- Analyse reported cases (severity, imputability, expected or unintended character) in the investigator if necessary
Skills and Requirements:
- Doctor of Medicine with or without specialization in oncology and / or autoimmune diseases,
- Significant and successful experience in pharmacovigilance with a minimum of 3 years in parent company
- Experience in drafting parts of product tolerance for study documents and regulatory records
- Expertise of French and international regulations on pharmacovigilance
- Fluent, spoken and written English
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 Sam Walker on +44 203 8569 336 or upload your CV on our website - www.proclinical.com.
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.