Senior Safety Aggregate Report Manager / PV Scientist

About the role

Lead global safety aggregate reporting and signal management projects, ensuring high‑quality deliverables for regulatory authorities and clients.

Key responsibilities

• Serve as the global lead for aggregate reporting, literature surveillance, and signal management across post‑marketing and clinical trial projects.
• Author and finalize PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, and respond to regulatory agency inquiries.
• Oversee literature safety surveillance, identify ICSR cases, and contribute to signal detection activities.
• Set up and manage safety management teams, define signaling strategies, and ensure full documentation and compliance.
• Provide training, mentorship, and quality checks for SARA staff and project teams.

Required profile

• Life‑science graduate (pharmacy, nursing or related) with 5‑10 years of pharmacovigilance experience.
• Proven ability to deliver aggregate safety reports and manage signal detection projects.
• Strong organizational, time‑management and communication skills.
• Fluent English, both spoken and written.

Required skills

• Pharmacovigilance and drug safety expertise.
• Aggregate reporting (PBRER, PSUR, DSUR, etc.).
• Signal detection and management.
• Literature safety surveillance.