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Safety Aggreg Report Manager

4-6 years
₹12–18 LPA
10 Aug. 5, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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