Safety Aggregate Data Analyst

3 days ago

Bengaluru, Karnataka, India beBeeAggregate Full time ₹ 9,00,000 - ₹ 12,00,000
Job Title: Safety Aggregate Report Specialist 2
Job Overview:

Apply your expertise to deliver high-quality Safety Aggregate Reports and Analytics (SARA) Center outputs, including safety aggregate reports, literature surveillance, signal management activities, and benefit-risk management documents. As a key member of the team, you will leverage your knowledge and skills to drive project success.

Essential Functions:
  1. Serve as the principal owner of SARA deliverables, ensuring timely completion in compliance with all applicable service level agreements (SLAs).
  2. Lead, author, and finalize aggregate reports, including PBRERs/PSURs, DSURs, PADERs, RMPs, ACOs, and line listings.
  3. Author responses to regulatory agency/Pharmacovigilance Risk Assessment Committee (PRAC) inquiries as required.
  4. Conduct ongoing literature safety surveillance for marketed and investigational products, identifying ICSRs from literature, evaluating events of special interest, and reviewing aggregate data.
  5. Act as Signal Management Lead on post-marketing and clinical trial projects, setting up, implementing, organizing, and leading safety management teams, establishing product signaling strategies, and authoring or QC reviewing signal management deliverables.
  6. Interface with clients and other functional groups within Lifecycle Safety and other business units as needed.
  7. Participate in internal and external audits and inspections as required.
  8. Contribute to departmental goals, such as utilization realization and productivity metrics.
  9. Read, acknowledge, and adhere to necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required.
Qualifications:
  • Bachelor's Degree in a Scientific or Healthcare discipline.
  • 3-9 years relevant work experience.

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