Pharmacovigilance QPPV (Qualified Person Responsible for Pharmacovigilance)
Company: rare metabolics life sciecnes private limited
- Location: Delhi, India
- Work mode: Remote
- Seniority: Entry level
- Employment type: Full-time
- Posted: 13 days ago
- Offer language: English
Job description
Role Description This full-time Pharmacovigilance QPPV (Qualified Person Responsible for Pharmacovigilance) role is a hybrid position based in Delhi, India, with flexibility for some work from home. The QPPV will oversee the pharmacovigilance system, ensuring continuous compliance with applicable regulatory requirements and company procedures. Daily responsibilities include reviewing safety data, assessing adverse event reports, and contributing to signal detection and risk management activities. The role involves preparing and reviewing safety-related regulatory submissions, maintaining PV documentation, and supporting audits and inspections. The QPPV will collaborate with clinical, medical, regulatory, and quality teams to promote a strong safety culture and timely communication of safety information.
Qualifications
- Candidates should possess strong expertise in Regulatory Requirements and Regulatory Affairs related to pharmacovigilance and medicinal product safety.
- Candidates should possess a solid background in Pharmacy and Medicine, with the ability to interpret clinical and safety data.
- Candidates should possess experience with Clinical Trials, including safety reporting, GCP, and coordination with study teams.
- Advanced knowledge of pharmacovigilance principles, risk management planning, and safety signal evaluation is beneficial.
- Relevant professional degree (e.g., PharmD, M.Pharm, MBBS, MD, or equivalent) with prior pharmacovigilance or drug safety experience is preferred.
- Strong analytical, documentation, and regulatory writing skills, with attention to detail and accuracy.
- Ability to work collaboratively in cross-functional teams, manage multiple priorities, and maintain high ethical and compliance standards.
- Familiarity with global PV regulations (e.g., EMA, FDA, ICH) and experience with safety databases and quality management systems is an advantage.
