Roles & Responsibilities
• Author, review, and finalize aggregate safety reports including PSUR, PBRER, DSUR, and RMP
• Perform signal detection, signal validation, and signal management activities
• Ensure compliance with global regulatory requirements (ICH, GVP, FDA, EMA)
• Collaborate with global safety, medical, and cross-functional teams
• Maintain high-quality regulatory documentation within defined timelines
• Support responses to health authority queries related to aggregate safety reports
• Ensure consistency, accuracy, and scientific integrity of safety data
Qualification
• Graduate or Postgraduate in Life Sciences
• B.Pharm / M.Pharm / PharmD / M.Sc or equivalent qualification
Experience
• Minimum 4+ years of hands-on experience in Pharmacovigilance
• Strong experience in aggregate report authoring OR signal management activities
• Experience working on global regulatory submissions preferred
Skills
• In-depth knowledge of pharmacovigilance regulations and guidelines
• Expertise in aggregate safety reporting and signal management
• Familiarity with global safety databases (preferred)
• Strong medical writing, analytical, and documentation skills
• Excellent communication and coordination abilities
• Ability to work independently in a remote environment
About the Organisation
IQVIA is a global leader in Human Data Science, providing advanced analytics, technology solutions, and clinical research services to the life sciences industry. With a strong global presence and focus on innovation, IQVIA supports pharmaceutical and biotech companies in improving healthcare outcomes worldwide.
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