Are you passionate about drug safety and pharmacovigilance? IQVIA, a global leader in clinical research and healthcare intelligence, is hiring a Safety Aggregate Report Specialist in Bangalore and Thane, Maharashtra, India. This full-time role offers an exciting opportunity to contribute to patient safety by authoring and reviewing critical safety reports, ensuring compliance with regulatory standards, and collaborating with global teams. If you have a background in pharmacovigilance, signal management, or literature surveillance, this role is your chance to advance your career with a top-tier organization.
Job Responsibilities
As a Safety Aggregate Report Specialist at IQVIA, you will play a pivotal role in ensuring drug safety and regulatory compliance. Your key responsibilities include:
- Authoring and Reviewing Reports: Act as the primary author or reviewer/QC for Safety Aggregate Reports (SARA), including PBRERs/PSURs, DSURs, PADERs, ACOs, device reports, and line listings.
- Signal Management: Conduct signal detection, validation, and evaluation for post-marketing and clinical trial projects, presenting findings in safety management team meetings.
- Literature Surveillance: Lead or support literature reviews for marketed and investigational products, identifying ICSRs, evaluating events of special interest, and contributing to aggregate reports.
- Regulatory Compliance: Author responses to regulatory agencies and Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, ensuring adherence to strict timelines.
- Collaboration: Interface with cross-functional teams, including Regulatory Reporting, Medical Writing, and Clinical Research, to deliver high-quality deliverables.
- Mentorship: Provide training and guidance to junior team members, fostering a culture of excellence and compliance.
- Project Management: Track project metrics, communicate issues, and participate in project review meetings to ensure client satisfaction.
- Audits and Inspections: Support internal and external audits to maintain compliance with IQVIA and customer SOPs.
Qualifications and Skills
To excel in this role, candidates should meet the following requirements:
- Education: Bachelor’s degree (required); advanced degree in life sciences or related field preferred.
- Experience: 1–3 years of relevant experience in drug safety, aggregate reporting, signal management, or literature surveillance (preferred).
- Technical Skills: Proficiency in Microsoft Office (Word, Excel, PowerPoint) and web-based applications.
- Knowledge: Strong understanding of medical terminology, SOPs, and pharmacovigilance regulations.
- Soft Skills:
- Excellent organizational and time management skills.
- Strong verbal and written communication skills.
- Ability to multitask, prioritize, and work independently.
- Attention to detail and accuracy.
- Self-motivated with a willingness to learn new skills.
- Additional Requirements: Equivalent combinations of education, training, and experience may be considered.
Why Join IQVIA?
Working at IQVIA offers unparalleled opportunities to grow in the pharmacovigilance and clinical research industry. Benefits include:
- Global Exposure: Collaborate with international teams and clients, gaining experience in a dynamic, global environment.
- Career Growth: Access mentorship, training, and opportunities to expand your expertise across Lifecycle Safety service lines.
- Impactful Work: Contribute to patient safety and innovative medical treatments that improve global health outcomes.
- Supportive Culture: Join a team that values collaboration, innovation, and professional development.
