Safety Aggregate Report Manager – Bengaluru, India
Work Mode: Hybrid
Employment Type: Full-Time
Requisition ID: R1495179
Job Description:
IQVIA is seeking a highly experienced Safety Aggregate Report Manager to lead global pharmacovigilance projects, including safety aggregate reporting, signal management, and literature surveillance. The role offers a strategic position within the Safety Aggregate Report and Analytics (SARA) Center, ensuring regulatory compliance and high-quality deliverables while mentoring team members and contributing to process improvement initiatives.
Key Responsibilities:
Act as global functional lead for safety aggregate reports, signal management, and literature surveillance.
Lead authoring and finalization of regulatory documents such as PBRERs, PSURs, DSURs, PADERs, RMPs, REMS, and agency responses.
Perform literature safety surveillance and manage ICSRs and events of special interest from the literature.
Lead signal detection and evaluation, setup signaling strategies, and guide teams in data analysis and documentation.
Oversee safety management teams on large or complex post-marketing and clinical projects.
Collaborate with cross-functional teams across regulatory, medical writing, real-world late phase, and IT departments.
Participate in audits and inspections, ensure documentation compliance, and lead audit preparations.
Mentor team members and oversee quality control of deliverables.
Contribute to resource planning, project metrics reporting, and participate in client review meetings.
Support continuous improvement through SOP reviews, process enhancements, and operational efficiency initiatives.
Maintain thorough knowledge of global pharmacovigilance regulations, Good Pharmacovigilance Practice (GVP), ICH, and GCP guidelines.
Required Qualifications & Skills:
Education: Bachelor's Degree in a Scientific or Healthcare discipline (mandatory).
Experience: 4–6 years of relevant work experience in pharmacovigilance and safety reporting.
Extensive knowledge of lifecycle safety processes, regulatory frameworks, and audit practices.
Strong leadership, mentoring, and project management skills with the ability to meet strict deadlines.
Excellent understanding of safety databases, reporting metrics, productivity KPIs, and signal detection strategies.
Outstanding written/verbal communication and client-facing presentation skills.
Proficiency in handling complex pharmacovigilance projects independently with high quality standards.
Collaborative mindset with the ability to motivate teams and drive cross-functional initiatives.
About IQVIA:
IQVIA is a global leader in clinical research and healthcare intelligence, offering cutting-edge solutions that improve patient outcomes and transform the life sciences industry. Join a team where your expertise in safety reporting can make a global impact.
Estimated Salary: ₹12–18 LPA (based on experience and seniority in pharmacovigilance roles)
Apply Now at IQVIA Careers
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