Senior Pharmacovigilance Specialist

Pharmacie du Mont SA seeks a Senior Pharmacovigilance Specialist to lead safety signal management and oversee aggregate reporting in an on-site role in Switzerland.

This position focuses on directing safety signal management workflows and synthesizing complex data for evaluation reports. The specialist is responsible for overseeing the preparation and finalization of aggregate safety documents, ensuring rigorous adherence to regulatory standards while supporting clinical trial activities through cross-functional collaboration.

Responsibilities

• Direct the detection, tracking, documentation, and evaluation of safety signals.
• Compile data from various sources to author comprehensive signal evaluation reports.
• Conduct literature reviews to pinpoint relevant safety information.
• Manage the creation, review, and completion of aggregate safety reports, including PSURs, DSURs, and Risk Management Plans.
• Address safety-related questions from regulatory bodies.
• Partner with Safety, Clinical Development, Medical Affairs, and Regulatory teams to support investigational programs.
• Apply clinical judgment to analyze case information and safety data.
• Lead Safety Signaling Team meetings to ensure alignment on safety strategies.

Requirements

• Ability to interpret and present scientific and medical data clearly in written and verbal formats.
• Deep expertise in pharmacovigilance processes, including signal management and regulatory compliance.
• Solid knowledge of global clinical trial and post-marketing safety regulations.
• Proficiency in Excel, PowerPoint, Word, and safety database systems.
• Proven leadership and collaboration skills within cross-functional environments.
• Strong organizational abilities with independent task prioritization.
• Degree in biological or natural sciences, health disciplines, or an advanced degree such as PhD, MPH, NP, or PharmD.
• Prior experience in pharmacovigilance, specifically in aggregate safety reporting and signal management.

About the company

Pharmacie du Mont SA operates within the life sciences sector, seeking to align exceptional talent with critical positions. The company values rigorous scientific analysis and regulatory compliance in its pharmacovigilance operations.

• Focus on matching exceptional people with fine positions in the life sciences industry.