Senior Patient Safety Specialist

Excelya Group; Paris; On-site; EUR 60,000 - 90,000; Full time

Job summary

Excelya Group is seeking an experienced Patient Safety professional for a six-month assignment. You will contribute to clinical safety activities, signal detection and benefit-risk assessment for assigned products.

The role requires strong medical writing, regulatory interaction and cross-functional collaboration. Key responsibilities include safety reviews of reports, signal detection, risk management, and preparation of safety documents.

Qualifications

• Medical degree, pharmacy degree, life sciences degree or equivalent relevant qualification.
• Significant experience in pharmacovigilance, patient safety and drug safety.
• Demonstrated expertise in signal detection, aggregate safety reporting, risk management, and benefit-risk evaluation.
• Intensive drug safety experience in clinical trials and post marketing safety studies.
• Strong understanding of global pharmacovigilance regulations and experience interacting with regulatory agencies.
• Strong clinical/scientific judgement and the ability to deliver clear, evidence-based recommendations.
• Excellent scientific writing and verbal communication skills and stakeholder management skills.

Responsibilities

• Conduct medical and clinical safety review of individual case safety reports and aggregate safety data.
• Support signal detection, validation, evaluation and tracking activities.
• Contribute to benefit-risk assessments for assigned products.
• Review and interpret safety data from clinical trials, post-marketing sources and other relevant databases.
• Identify emerging safety concerns and assess their potential impact on patients and product safety profiles.
• Prepare and contribute to safety documents, including signal evaluation reports, safety reviews and benefit-risk assessments.
• Provide medical and pharmacovigilance input into risk management activities.
• Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Epidemiology and other cross-functional teams.
• Support responses to internal and external safety-related questions.
• Ensure that all activities are conducted in accordance with applicable pharmacovigilance regulations, company procedures and quality standards.
• Contribute to safety governance meetings and communicate key findings clearly to stakeholders.

Skills

Pharmacovigilance

Patient safety

Signal detection

Risk management

Safety reporting

Stakeholder management

Medical writing

Verbal communication

Education

Medical degree

Pharmacy degree

Life sciences degree

Job description

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

We are looking for an experienced Patient Safety professional on a six month assignment. The successful candidate will contribute to clinical safety activities, signal detection and benefit-risk assessment for assigned products.

Key Responsibilities:

• Conduct medical and clinical safety review of individual case safety reports and aggregate safety data.
• Support signal detection, validation, evaluation and tracking activities.
• Contribute to benefit-risk assessments for assigned products.
• Review and interpret safety data from clinical trials, post-marketing sources and other relevant databases.
• Identify emerging safety concerns and assess their potential impact on patients and product safety profiles.
• Prepare and contribute to safety documents, including signal evaluation reports, safety reviews and benefit-risk assessments.
• Provide medical and pharmacovigilance input into risk management activities.
• Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Epidemiology and other cross-functional teams.
• Support responses to internal and external safety-related questions.
• Ensure that all activities are conducted in accordance with applicable pharmacovigilance regulations, company procedures and quality standards.
• Contribute to safety governance meetings and communicate key findings clearly to stakeholders.

• Medical degree, pharmacy degree, life sciences degree or equivalent relevant qualification.
• Significant experience in pharmacovigilance, patient safety and drug safety.
• Demonstrated expertise in signal detection, aggregate safety reporting, risk management, and benefit-risk evaluation.
• Intensive drug safety experience in clinical trials and post marketing safety studies.
• Strong understanding of global pharmacovigilance regulations and experience interacting with regulatory agencies.
• Strong clinical/scientific judgement and the ability to deliver clear, evidence-based recommendations
• Excellent scientific writing and verbal communication skills and stakeholder management skills.

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique.

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe'sleading mid-size CROwith thebest employee experience. Ourone-stop provider service modeloffering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with caremeans benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.