Job opening for Head of Pharmacovigilance and Global Safety
Chromosome Recruitment is looking for his client Biotechnology company specialised in Oncology, Neurology and Inflammatory Diseases a:
Head of Pharmacovigilance
Our Client is a pharmaceutical company specializing in the development of tyrosine kinase inhibitors in human and veterinary medicine.
Our Client has an extensive clinical development program in oncology as well as in inflammatory and neurodegenerative diseases.
Our Client is convinced that professional equality between women and men is a factor in the performance and modernity of a company, and that employee diversity is a source of wealth and contributes to strengthening social cohesion.
Responsibilities
- Prepare the pharmacovigilance part of Marketing Authorization and regulatory dossiers (IND, NDA, Scientific Advice, …)
- Ensure that the pharmacovigilance system can meet international regulatory requirements
- Assess the risk / benefit of the products in all indications
- Prepare the DSURs, PSURs, PDERs, local synthesis and pharmacovigilance reports
- Implement and monitor the set-up of pharmacovigilance procedures
- 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
- Analyze the reported cases with the investigator if necessary
Skills and qualifications:
- MD – 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
Additional information
- Permanent position
- Based in Paris
- Starting date ASAP
- Salary & package to define according skills and experience