Unichem Laboratories is a leading Indian pharmaceutical company with a strong presence in domestic and international markets. Known for its high-quality formulations and compliance with global regulatory standards, Unichem specializes in generics, APIs, and innovative drug development. The company has a strong pharmacovigilance (PV) division ensuring drug safety and regulatory adherence.
Detailed Job Description
Job Title: Submission Specialist – Pharmacovigilance
Location: Mumbai
Experience: 2-6 years
Employment Type: Full-time, Permanent
Key Responsibilities:
✔ ICSR Management: Book-in, data entry, and quality review of Individual Case Safety Reports (ICSR) in the Argus database
✔ Global Submissions: Ensure timely ICSR submissions to global health authorities (FDA, EMA, etc.)
✔ Vendor Management: Coordinate with third-party vendors for case processing and compliance
✔ SOP Training: Conduct training sessions on Standard Operating Procedures (SOPs) as needed
✔ Regulatory Compliance: Maintain submission trackers, audit readiness, and correspondence with health authorities
Desired Skills & Qualifications:
✅ Education: B.Pharma / M.Pharma (Any Specialization)
✅ Technical Skills:
- Strong knowledge of GVP (Good Pharmacovigilance Practices) guidelines
- Experience with ICSR submissions and Argus safety database
- Familiarity with global regulatory timelines (FDA, EMA, etc.)
✅ Soft Skills: Good communication, attention to detail, and problem-solving abilities
Eligibility & Benefits
Eligibility Criteria:
- Experience: 2-6 years in pharmacovigilance, ICSR submissions, or drug safety
- Preferred: Candidates with prior experience in vendor management & regulatory submissions
Employee Benefits:
🔹 Competitive salary (Not disclosed but industry-standard)
🔹 Opportunity to work in a reputed pharmaceutical company
🔹 Career growth in global pharmacovigilance & regulatory affairs
🔹 Structured training & development programs
How to Apply
