Safety Aggregate Report Specialist – Bengaluru
Job Summary:
IQVIA is seeking a Safety Aggregate Report Specialist (SARA Specialist) to lead the preparation of safety aggregate reports, conduct literature surveillance, and manage signal detection activities for investigational and marketed products. This role is ideal for professionals with 3–4 years of experience in pharmacovigilance, lifecycle safety services, and regulatory submissions.
Key Responsibilities:
Act as the principal owner for Safety Aggregate Report and Analytics (SARA) deliverables, ensuring adherence to service level agreements.
Lead and author aggregate safety reports such as PBRERs/PSURs, DSURs, PADERs, RMPs, ACOs, and line listings.
Conduct literature safety surveillance and identify individual case safety reports (ICSRs) from literature sources.
Serve as Signal Management Lead, setting up signaling strategies, performing validation, evaluation, and documentation of signals.
Lead safety responses to regulatory authorities and author justification documents for labeling updates.
Collaborate with cross-functional teams (Regulatory Affairs, Medical Writing, Safety Operations, etc.) to ensure quality deliverables.
Participate in audits, inspections, and project review meetings while ensuring compliance with SOPs and regulatory guidelines.
Mentor and train junior staff on pharmacovigilance deliverables and processes.
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences or Healthcare discipline.
3–4 years of pharmacovigilance or lifecycle safety experience.
Strong knowledge of GVP, GCP, ICH guidelines, and global regulatory requirements.
Proficiency in Microsoft Office and web-based tools.
Excellent skills in report authoring, data review, and regulatory response preparation.
Strong organizational, time management, and project leadership skills.
Attention to detail with the ability to meet strict deadlines and manage competing priorities.
Effective communication, mentoring, and team collaboration abilities.
Perks & Benefits:
Work with global pharmacovigilance experts on critical safety and risk management projects.
Access to advanced training programs and leadership mentoring.
Competitive compensation and growth opportunities within IQVIA.
Company Description:
IQVIA is a global leader in clinical research, pharmacovigilance, and healthcare analytics, providing innovative solutions that improve patient outcomes and accelerate drug development. With a strong focus on safety, compliance, and technology, IQVIA supports top life sciences companies worldwide.
Work Mode: On-site – Bengaluru, India.
Call-to-Action:
Ready to advance your career in pharmacovigilance? Apply now for the Safety Aggregate Report Specialist position at IQVIA in Bengaluru.
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