Aggregate Reports Specialist
About the Role
Roles & Responsibilities
• Preparation and review support of PSUR, PBRER, and DSUR
• Compile data and perform benefit–risk evaluation
• Conduct signal detection and trend analysis
• Ensure compliance with global aggregate reporting timelines
Qualification
• B.Pharm, M.Pharm, Pharm.D, Msc, BSc, or other Lifesciences degree
Experience
• 4–6 years of relevant pharmacovigilance experience
Skills
• Strong understanding of global pharmacovigilance regulations (ICH, GVP, FDA, EMA guidelines)
• Experience with safety databases (Argus/ArisG preferred)
• Strong analytical and documentation skills
• Ability to work in a compliance-focused, quality-driven environment
About The Company
Medifodil Smart Pharma Solutions is an expanding pharmacovigilance department offering high-growth opportunities in a quality-driven environment. With a focus on regulatory compliance and patient safety, Medifodil provides comprehensive solutions across ICSR, aggregate reporting, and PV Quality Assurance (QA).
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