SAFETY PERIODIC REPORT LEAD

Job Title

Periodic Safety Reports Manager (Pharmacovigilance)

Company Overview

We are a human‑scale, international, independent pharmaceutical group governed by a Foundation, committed to therapeutic progress for the benefit of patients. Our R&D Institute is located at Paris‑Saclay, within one of the world’s top innovation clusters.

Responsibilities

• Participate in planning of safety periodic reports: PSURs, PBRERs, and clinical‑trial‑required reports (DSURs, 6 monthly SUSAR line listing), as well as other unit reports (clinical overview, renewals files “Ad-cov”, others).
• Prepare, draft, and coordinate safety periodic reports (PSURs, PBRERs, DSURs, 6 monthly reports/SUSAR line listing, and other safety reports under unit responsibility) in collaboration with operational teams inside and outside Global Safety.
• Supervise the management of the activities delegated to the external service provider in charge of PSR preparation within their scope.
• Prepare and ensure submission of responses to PBRER/PSUR assessments and other responses related to periodic safety reports for clinical trials, working closely with cross‑functional units.
• Maintain and update Risk Management Plans (RMPs) following significant new safety information or safety concerns raised by the MAH or Competent Authorities.
• Oversee submission of periodic reports to Competent Authorities and transmission to subsidiaries and partners, ensuring compliance with regulatory, internal, and partnership‑agreement deadlines; supervise traceability and archiving of submissions.
• Participate in the impact assessment of regulatory intelligence within the scope of activities.
• Contribute to cross‑functional working groups.
• Create and maintain quality documents related to the scope of activities, ensuring alignment with regulatory requirements.
• Provide periodic activity reporting to the direct line manager.
• Identify potential risks within the scope of activities and immediately inform the direct line manager.
• Contribute to preparing inspections and audits by business partners for activities under the periodic reports unit.
• Ensure all activities are managed in compliance with regulatory requirements, company policies/procedures at global levels, and vigilance agreements with third‑party business partners.

Qualifications

• Education: Physician, Pharmacist, or life science degree.
• Experience:
  • At least 6 years of experience within the pharmaceutical industry in the PV field at the corporate level and in an international environment, including analysis of PV data.
  • 3–4 years of relevant experience.
• Hard skills:
  • Proficiency in safety databases and software.
  • Safety data analysis and interpretation.
  • Expertise in writing periodic safety reports.
  • Very good knowledge of regulatory requirements at the worldwide level.
  • Great communication in English.
• Leadership skills:
  • Clear and effective communication.
  • Rigor and attention to detail.
  • Proactivity and initiative.
• Soft skills:
  • Analytical and critical thinking.
  • Adaptability.
  • Collaboration spirit.
  • Time management and organization.

Benefits

• 13th‑month salary, contribution to results bonus, profit‑sharing / employee participation, and transportation allowance.
• 27 days of paid leave, plus 23 RTT days (reduced working hours).
• Supplemental pension plan, health insurance with 60% company contribution, and a comprehensive provident scheme.
• Flexible remote work options depending on the role.
• On‑site company restaurant, and a wide range of employee committee (CSE) activities and associations.

We are committed to equal opportunities and developing talents in all their diversity.