Senior Patient Safety Specialist (6-Month) – PV Expert

Excelya; Paris; On-site; EUR 50,000 - 67,000; Full time

Job summary

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

Responsibilities include safety data review, risk management input, and collaboration with Clinical Development, Regulatory, Medical Affairs, and Epidemiology teams to ensure alignment with global pharmacovigilance regulations and company standards.

Qualifications

• Experience in pharmacovigilance, patient safety and drug safety.
• Demonstrated expertise in signal detection, aggregate safety reporting and risk management.
• Extensive drug safety experience in clinical trials and post-marketing safety studies.

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

Drug safety

Clinical trials

Education

Medical / Pharmacy / Life sciences degree

Job description

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

Responsibilities include safety data review, risk management input, and collaboration with Clinical Development, Regulatory, Medical Affairs, and Epidemiology teams to ensure alignment with global pharmacovigilance regulations and company standards.