Are you passionate about pharmacovigilance and ensuring patient safety? IQVIA, a global leader in clinical research and healthcare intelligence, is hiring a Safety Aggregate Report Specialist for its Safety Aggregate Report and Analytics (SARA) Center in Bangalore and Thane, Maharashtra. This full-time role offers an exciting opportunity to contribute to critical safety deliverables, including aggregate reports, literature surveillance, and signal management. With a deadline to apply by August 8, 2025, now is the time to join a dynamic team dedicated to improving patient outcomes worldwide. Explore this pharmacovigilance job opportunity and advance your career with IQVIA!
Key Responsibilities
As a Safety Aggregate Report Specialist, you will play a pivotal role in ensuring compliance with global pharmacovigilance regulations. Your responsibilities include:
- Leading Aggregate Report Creation: Author and finalize safety reports such as PBRERs/PSURs, DSURs, PADERs, RMPs, ACOs, and line listings, ensuring compliance with service level agreements (SLAs).
- Regulatory Responses: Draft responses to inquiries from regulatory agencies and the Pharmacovigilance Risk Assessment Committee (PRAC).
- Literature Surveillance: Conduct ongoing safety surveillance for marketed and investigational products, identifying Individual Case Safety Reports (ICSRs) and evaluating events of special interest.
- Signal Management: Lead signal detection, validation, and evaluation activities, updating signaling strategies and documenting outcomes.
- Benefit-Risk Evaluation: Analyze and summarize aggregate safety data to identify signals and perform benefit-risk assessments.
- Cross-Functional Collaboration: Work with teams like Regulatory Affairs, Medical Writing, and Clinical Research to ensure seamless project execution.
- Mentorship & Training: Provide guidance to junior team members and ensure knowledge sharing within the team.
- Audits & Compliance: Participate in internal and external audits, adhering to IQVIA and client SOPs, Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP).
Qualifications
To excel in this role, candidates should meet the following requirements:
- Education: Bachelor’s degree in a scientific or healthcare discipline (required).
- Experience: 3-4 years of relevant work experience in pharmacovigilance or clinical research (preferred).
- Regulatory Knowledge: Strong understanding of global, regional, and local regulatory requirements, including GCP, GVP, and ICH guidelines.
- Technical Skills: Proficiency in Microsoft Office (Word, Excel, PowerPoint) and web-based applications.
- Soft Skills: Excellent organizational, time management, and communication skills, with a proven ability to meet strict deadlines and work independently.
- Attention to Detail: High accuracy and quality standards in report writing and data analysis.
- Leadership: Demonstrated project management and mentoring abilities.
- Flexibility: Willingness to adapt to changing priorities and learn new skills.
An equivalent combination of education, training, and experience will also be considered.
Benefits of Joining IQVIA
- Global Impact: Contribute to innovative medical treatments that improve patient outcomes worldwide.
- Career Growth: Access mentorship, training, and opportunities to work on cutting-edge pharmacovigilance projects.
- Collaborative Environment: Work with cross-functional teams in a supportive, dynamic setting.
- Industry Leadership: Be part of IQVIA, a trusted name in clinical research and healthcare intelligence.
