IQVIA is seeking a PV Scientist to join our Safety Aggregate Report and Analytics (SARA) Center team. In this role, you will be responsible for:
- Leading and authoring safety aggregate reports (PBRERs/PSURs, DSURs, PADERs, RMPs, ACOs).
- Conducting literature surveillance for marketed and investigational products.
- Managing signal detection, validation, and evaluation for pharmacovigilance activities.
- Responding to regulatory agency inquiries (e.g., PRAC, FDA, EMA).
- Collaborating with cross-functional teams (Regulatory Affairs, Medical Safety, Clinical Research, etc.).
- Ensuring compliance with GVP, ICH guidelines, and SOPs.
- Supporting audits, inspections, and training initiatives.
Key Responsibilities
✔ Lead and finalize safety aggregate reports within SLAs.
✔ Perform ongoing literature surveillance for safety signals.
✔ Act as Signal Management Lead for post-marketing and clinical trial projects.
✔ Author responses to regulatory queries and support labeling updates.
✔ Mentor junior team members and ensure GDP (Good Documentation Practices).
✔ Participate in technology/innovation initiatives to improve PV processes.
Qualifications & Skills
✅ Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field.
✅ 2-3 years of experience in pharmacovigilance, drug safety, or signal management.
✅ Strong knowledge of GCP, GVP, ICH guidelines, and regulatory requirements.
✅ Proficiency in Microsoft Office (Word, Excel, PowerPoint).
✅ Excellent communication, organizational, and project management skills.
✅ Ability to work independently and meet strict deadlines.
About IQVIA
IQVIA is a global leader in clinical research, healthcare analytics, and commercial solutions for the life sciences industry. We provide intelligent insights to accelerate drug development and improve patient outcomes. With a presence in 100+ countries, IQVIA is at the forefront of healthcare innovation.
How to Apply
📌 Last Date: June 27, 2025
