Hiring Freshers in Pharamcovigilance at Lincoln Pharmaceuticals

Lincoln Pharmaceuticals, a well-established Indian pharmaceutical company, is hiring a Pharmacovigilance Associate for its Ahmedabad location. This opportunity is ideal for freshers or early-career professionals (0–1 year experience) seeking hands-on exposure in drug safety, ICSR processing, PSURs, and global pharmacovigilance regulations including EMA, EU GVP, ICH, and FDA guidelines.

With increasing regulatory focus on patient safety, this role provides strong career growth in pharmacovigilance and regulatory compliance, especially for M.Pharm / B.Pharm / Life Sciences graduates.

🏢 Company Details

• Company: Lincoln Pharmaceuticals
• Industry: Pharmaceuticals & Drug Safety
• Location: Ahmedabad, Gujarat
• Experience Required: 0–1 year
• Openings: 1
• Preference: Women candidates (as per employer)

🧪 Key Responsibilities – Pharmacovigilance Associate

• Ensure compliance with EMA, EU GVP, ICH E2A/E2B, FDA, and local PV guidelines
• Maintain pharmacovigilance documentation including SOPs and PV Master File (PSMF)
• Assist during regulatory inspections, audits, and CAPA implementation
• Support preparation and review of:
  • ICSRs
  • PSURs / PBRERs
  • DSURs
  • Risk Management Plans (RMPs)
• Submit safety reports to EudraVigilance and other safety databases
• Perform literature screening and safety data evaluation
• Assist in signal detection, risk minimization activities, and safety meetings
• Support preparation of SmPC, PIL, and package leaflets
• Code and review adverse events using MedDRA and WHO-DD
• Maintain accurate safety databases, trackers, and compliance logs
• Complete mandatory pharmacovigilance trainings and stay updated with PV regulations

🎓 Qualifications & Skills Required

• Education:
  • M.Pharm / B.Pharm / Pharm.D / MSc (Life Sciences or related)
• Experience:
  • 0–1 year (Freshers with PV training can apply)
• Technical Knowledge:
  • Pharmacovigilance regulations (EMA, EU GVP, ICH, FDA)
  • ICSR processing & safety reporting
  • MedDRA & WHO-DD coding (basic understanding acceptable)
• Soft Skills:
  • Attention to detail
  • Regulatory compliance mindset
  • Good documentation and communication skills

💰 Salary & Benefits

• Salary Range: ₹50,000 – ₹2,00,000 per annum (as per experience & skills)
• Exposure to global pharmacovigilance systems
• Strong foundation for careers in:
  • Drug Safety Associate
  • PV Scientist
  • Regulatory Affairs & Safety Operations
• Work with cross-functional clinical, regulatory, and quality teams

📝 How to Apply

Application Link