Lead, Safety Periodic Reports (DSUR/PSUR)

Excelya Group; Saclay; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading health company in Saclay is seeking a Pharmacovigilance Specialist to lead the development of safety periodic reports. The ideal candidate has a strong background in pharmacovigilance and a Master's degree in Life Sciences or Pharmacy. You will contribute to high-quality pharmacovigilance services, ensuring compliance with industry regulations while working in a dynamic team environment. Fluency in both French and English is required, along with excellent analytical and communication skills.

Prestations

Inclusive work environment

Passion for science

Opportunities for growth through diverse projects

Qualifications

• Strong background in pharmacovigilance and experience in writing safety periodic reports.
• Proficient knowledge of regulatory guidelines (e.g., GVP, ICH) and best practices.
• Fluency in French and English (both written and spoken).

Responsabilités

• Prepare, coordinate, and maintain product safety profiles.
• Support the planning and delivery of periodic safety reports.
• Draft expert safety reports and responses to Health Authority questions.
• Lead and update Risk Management Plans for assigned products.
• Ensure proper tracking and submission of safety reports.

Connaissances

Analytical skills

Communication

Interpersonal skills

Teamwork

Attention to detail

Formation

Master’s degree in Life Sciences or Pharmacy

Description du poste

A leading health company in Saclay is seeking a Pharmacovigilance Specialist to lead the development of safety periodic reports. The ideal candidate has a strong background in pharmacovigilance and a Master's degree in Life Sciences or Pharmacy. You will contribute to high-quality pharmacovigilance services, ensuring compliance with industry regulations while working in a dynamic team environment. Fluency in both French and English is required, along with excellent analytical and communication skills.