Aggregate Report Specialist

Role & Responsibilities
• Analyze, review, and interpret non-clinical and clinical safety data
• Author and perform quality review of aggregate safety reports including PSUR, PBRER, DSUR, and PADER
• Prepare Addendum to Clinical Overview (ACO) as per regulatory requirements
• Conduct literature searches and summarize relevant safety publications
• Generate Periodic Safety Line Listings (PSLL) from safety databases
• Handle regulatory authority and PRAC queries related to aggregate reports
• Maintain trackers, reconcile data, and ensure timely submissions
• Collaborate with Pharmacovigilance, Safety, and Regulatory Affairs teams
• Train and mentor pharmacovigilance associates
• Ensure compliance with ICH, GCP, and global pharmacovigilance regulations

Qualification
• Degree in Life Sciences or Pharmacy including B.Pharm, M.Pharm, Pharm.D, MSc, or BSc
• Strong academic background in pharmacovigilance and drug safety

Experience
• 1–3 years of experience in aggregate report authoring
• Minimum 1 year of experience in quality review of aggregate reports
• Hands-on exposure to PSUR, PBRER, DSUR, and PADER

Skills
• Strong knowledge of global pharmacovigilance regulations and safety surveillance
• Proficiency in MS Word, Excel, and Outlook
• Excellent written, verbal, and interpersonal communication skills
• Strong organisational, documentation, and time management abilities
• Ability to multitask and meet strict regulatory timelines
• Client interaction and issue resolution skills

About the Company
• Sitero is a global provider of clinical, regulatory, and pharmacovigilance services, Supports global safety and regulatory teams across multiple geographies.