(Pharmacovigilance System Master File), XEVMPD (Extended EudraVigilance Medicinal Product Dictionary), and Safety Variation Submissions. This is an on-site role in Noida, offering an excellent opportunity to grow in the pharmaceutical regulatory and drug safety domain.
Key Responsibilities:
- Maintain and update the Pharmacovigilance System Master File (PSMF) in compliance with regulatory requirements.
- Manage XEVMPD submissions and ensure accurate medicinal product data in the EudraVigilance database.
- Handle Safety Variation Submissions and support regulatory documentation.
- Ensure compliance with EU GVP (Good Pharmacovigilance Practices) and global pharmacovigilance regulations.
- Collaborate with cross-functional teams for pharmacovigilance audits and inspections.
- Assist in preparing Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and other safety documents.
Requirements:
- 1–2 years of experience in pharmacovigilance, preferably in PSMF, XEVMPD, and regulatory submissions.
- Strong understanding of EU pharmacovigilance regulations, GVP, and drug safety databases.
- Proficiency in EudraVigilance, EMA submissions, and safety data management.
- Excellent documentation and communication skills.
- B.Pharm / M.Pharm / Life Sciences / Pharmacy graduates preferred.
About the Company
We are a leading pharmaceutical and regulatory consulting firm dedicated to ensuring drug safety and compliance. Our expertise spans pharmacovigilance, regulatory submissions, and compliance management. Through our platform PharmaBharat.com, we provide industry insights, job opportunities, and regulatory updates to professionals in the pharma sector.
How to Apply
If you meet the qualifications, send your resume to careers@soterius.com with the subject line:
“Application for PSMF and XEVMPD Role”.
📍 Location: Noida (Work from Office)
🔍 Job Type: Full-time
