SAFETY PERIODIC REPORT LEAD

About our R&D Institute in Paris Saclay:

At the heart of one of the world's top eight innovation clusters, the Servier R&D Institute at Paris-Saclay is where visionary science meets a powerful global ecosystem. By uniting our Group's innovation potential with this prestigious center of excellence, we are not only accelerating the future of therapeutic discovery but also championing the global influence of French research.

Are you a fast-learning professional passionate about patient safety and global pharmacovigilance? We are seeking a Periodic Safety Reports Manager (Pharmacovigilance) to join our Periodic Reports Unit within Global Safety. In this role, you will support the planning, authoring, submission, and lifecycle management of global periodic safety reports and risk management plans, ensuring compliance with worldwide regulations.

Why Join Us?

• Make a direct impact on patient safety by leading Safety Periodic Reports including PSUR, PBRER, DSUR, and RMP activities.
• Work cross-functionally with Global Safety, subsidiaries, partners, and competent authorities.
• Operate in a truly international, corporate environment with broad visibility.
• Drive quality, inspection readiness, and continuous improvement of PV processes and documentation.
• Expand your expertise in worldwide regulatory requirements and safety data analysis.

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 his/her 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.

Profile:

• 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.

Recruitment Process:

Our standard recruitment journey includes the following steps:

• Prequalification Interview
• Interview with the Manager
• Interview with Talent Acquisition Team / Human Resources
• Reference Check Process

At one stage of the process, we would be delighted to welcome you to our site to meet in person and share the environment where we work every day to transform patients' lives!

Please note that this recruitment process may be adapted based on the specific requirements of the position.

Our 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