Cronus Pharma is a leading pharmaceutical company dedicated to improving global healthcare through innovative drug development and robust pharmacovigilance practices. With a strong commitment to regulatory compliance and patient safety, we provide a dynamic work environment for professionals passionate about pharmacovigilance and drug safety monitoring.
Detailed Job Description
Key Responsibilities:
✔ Case Processing & Evaluation – Review and process adverse event reports from clinical trials, post-marketing surveillance, and other sources.
✔ Vendor & Stakeholder Coordination – Work with contract manufacturers, CROs, and internal teams to ensure PV compliance.
✔ FDA & Regulatory Reporting – Prepare and submit PADERS, 15-Day Alert Reports, and other safety documents.
✔ Signal Detection & Risk Management – Analyze safety data to identify potential risks and support risk mitigation strategies.
✔ SOP Management & Audits – Develop and maintain pharmacovigilance SOPs, support FDA and partner audits.
✔ Cross-Functional Collaboration – Train internal teams on PV requirements and ensure compliance with ICH, FDA (21 CFR Part 11), and global regulations.
Eligibility & Requirements
✅ Education: Bachelor’s degree in Pharmacy, Life Sciences, Nursing, or related healthcare field.
✅ Experience:
- PV Specialist: 3+ years in pharmacovigilance (pharma/biotech/medical devices).
- Sr. PV Specialist: 5+ years with leadership experience in PV operations.
✅ Skills: - Strong knowledge of FDA, ICH-GCP, EMA guidelines.
- Experience with Argus, Veeva, or other safety databases.
- Excellent communication, analytical, and documentation skills.
Benefits & Perks
🔹 Competitive salary & performance bonuses
🔹 Health insurance & wellness programs
🔹 Flexible work options (hybrid/remote depending on role)
🔹 Continuous learning & career growth opportunities
🔹 Collaborative work culture with industry experts
How to Apply?
Interested candidates can share their updated CV with the following details to hr@cronuspharma.com
- Current CTC & Expected Salary
- Notice Period
- Relevant PV Experience Summary
