Pharmacovigilance Regulatory Reporting Specialist

About the role

The Regulatory Reporting Specialist will support the submission of safety reports to regulatory authorities, ensuring that all safety data received from various sources is accurately reviewed, assessed, and processed. This remote position works under the guidance of senior operation team members within a global life‑sciences environment.

Key responsibilities

• Process safety data in accordance with applicable regulations, guidelines, SOPs, and project requirements.
• Distribute safety reports and data to internal and external stakeholders while maintaining compliance with quality, productivity, and delivery standards.
• Track case progress against project plans and identify any quality issues for escalation.
• Liaise with functional team members and healthcare professionals to resolve project‑related queries.
• Participate in project team meetings and provide feedback on challenges, successes, and improvement opportunities.

Required profile

• Bachelor’s degree in life sciences.
• 2‑3 years of experience in pharmacovigilance activities, specifically regulatory reporting.
• Advanced proficiency in English.

Required skills

• Proficiency with the Argus safety database.
• Strong knowledge of medical terminology and relevant safety regulations.

What we offer

• 100% remote work arrangement.
• Opportunity to work with a leading global provider of clinical research and healthcare intelligence.