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
- 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.
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 [click here]">[click here]. 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.