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Are you passionate about pharmacovigilance, safety analytics, and regulatory compliance? IQVIA, a global leader in clinical research and life sciences intelligence, invites skilled professionals to apply for the role of Safety Aggregate Report Specialist II in Bangalore and Thane, India.
This role offers a dynamic opportunity to work on aggregate safety reporting, signal management, and risk evaluation for global pharmaceutical and biotech clients.
Key Responsibilities
As a Safety Aggregate Report Specialist II, you will:
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- Lead and author safety aggregate reports such as PBRERs/PSURs, DSURs, PADERs, and RMPs.
- Conduct literature surveillance and assist with ICSR identification, signal validation, and safety data evaluation.
- Manage signal detection activities and author safety responses to regulatory authorities and PRAC.
- Collaborate across departments—Regulatory Affairs, Medical Writing, Clinical Research, and Quality.
- Participate in audits, ensure adherence to GVP/GCP/ICH guidelines, and maintain high-quality documentation.
- Mentor junior team members and contribute to departmental productivity and innovation goals.
Qualifications & Skills
- Bachelor’s degree in a scientific or healthcare discipline (mandatory).
- 3–4 years of relevant experience in pharmacovigilance or lifecycle safety.
- Strong understanding of global regulatory frameworks, including ICH, GVP, and GCP.
- Proficient in Microsoft Office, data analytics, and report writing.
- Exceptional attention to detail, communication, and project management skills.
- Ability to work independently, manage tight deadlines, and mentor others effectively.
Why Join IQVIA?
- Be part of a world-leading healthcare intelligence organization.
- Collaborate with global teams in a supportive, innovation-driven environment.
- Access opportunities for career advancement, training, and upskilling.
- Work on diverse projects that impact public health and patient safety.
How to Apply
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