Aggregate Report Specialist

Roles & Responsibilities:
• Analyze, review, and interpret non-clinical and clinical safety data
• Author and quality review aggregate reports including PSUR, PBRER, DSUR, PADER, and Addendum to Clinical Overview (ACO)
• Perform literature searches and summarize relevant safety publications
• Generate Periodic Safety Line Listings (PSLL) from safety databases
• Handle regulatory authority and PRAC inquiries
• Maintain trackers, reconcile data, and ensure on-time submissions
• Collaborate with Pharmacovigilance, Safety, and Regulatory Affairs teams
• Train and mentor pharmacovigilance associates
• Ensure compliance with ICH, GCP, and global PV regulations

Qualification:
• Degree in Life Sciences / Pharmacy (B.Pharm, M.Pharm, M.sc, PharmD, or equivalent)

Experience:
• 1–3 years in aggregate report authoring
• Minimum 1 year in quality review of aggregate reports
• Strong knowledge of pharmacovigilance regulations and safety surveillance

Skills:
• Hands-on experience with PSUR, PBRER, DSUR, and PADER
• Proficiency in MS Word, Excel, and Outlook
• Excellent written, verbal, and interpersonal communication skills
• Strong organizational and documentation skills
• Ability to multitask and meet tight timelines
• Client interaction and issue resolution capabilities

About the Organization:
Sitero is a leading global provider of clinical, regulatory, and pharmacovigilance services, offering career growth and exposure to global safety teams, regulatory interactions, and specialized domains in drug safety and regulatory medical writing.