Unichem Laboratories is currently hiring for multiple Pharmacovigilance roles in Mumbai (Kandivali), offering excellent opportunities for professionals with experience in PV operations, literature review, and aggregate reporting. These openings are ideal for candidates with B.Pharm or M.Pharm backgrounds seeking growth in drug safety and regulatory compliance.

With increasing global focus on drug safety, risk management, and regulatory reporting, these roles provide exposure to ICH guidelines, GVP modules, and international pharmacovigilance systems.

🔬 Available Roles

1. Officer – Pharmacovigilance (Quality & Literature Review)

• Experience: 2–5 years
• Focus: Literature screening, ICSR triage, Argus database, quality review

2. Officer – Pharmacovigilance (Aggregate Report Drafting)

• Experience: 1–6 years
• Focus: PSUR, PADER, PBRER, RMP preparation and compliance

3. Executive / Assistant Manager – Aggregate Reporting

• Experience: 7–12 years
• Focus: Team management, aggregate reporting oversight, audits, PSMF

📋 Key Responsibilities

• Perform literature screening and case identification for adverse events
• Conduct ICSR triage, booking, and data entry in Argus Database
• Prepare and review aggregate safety reports (PSUR, PADER, PBRER)
• Ensure compliance with GVP modules, ICH guidelines, and FDA regulations
• Manage global submissions and EudraVigilance screening
• Develop and maintain SOPs, Work Instructions (WIs), and PV documentation
• Support Risk Management Plans (RMPs) and regulatory updates
• Conduct training sessions for PV teams and stakeholders
• Perform reconciliation activities with partners and QPPV
• Assist in audit readiness and compliance monitoring

🎓 Qualifications & Skills

• Education: B.Pharm / M.Pharm
• Strong knowledge of:
  • Pharmacovigilance (PV) processes
  • GVP Modules & ICH Guidelines
  • Aggregate reporting (PSUR, PADER, PBRER)
• Experience with Argus Safety Database
• Good communication and analytical skills
• Attention to detail and regulatory understanding

💼 Benefits of Working at Unichem

• Exposure to global pharmacovigilance systems
• Hands-on experience in aggregate reporting & regulatory submissions
• Career growth in drug safety and medical writing
• Opportunity to work with cross-functional global teams
• Strong learning environment with training and SOP development

📍 Job Location

• Mumbai (Kandivali), Maharashtra, India

💰 Salary (Estimated)

• Officer Level: ₹4.5 – ₹8 LPA
• Assistant Manager: ₹10 – ₹18 LPA

(Based on industry benchmarks for pharmacovigilance jobs in Mumbai)

📥 How to Apply

Application Link For Officer – Pharmacovigilance (Quality & Literature Review)

Application Link For Officer – Pharmacovigilance (Aggregate Report Drafting)

Application Link For Executive / Assistant Manager – Aggregate Reporting