Looking to advance your career in pharmacovigilance signal management? A strong opportunity is now open for an experienced Pharmacovigilance Specialist in Dholka (near Ahmedabad). This role is ideal for professionals with hands-on expertise in PADER reporting, signal management, and PV compliance systems.

If you have 5–8 years of experience in drug safety and want to work in a regulated, quality-driven environment, this role offers exposure to global PV operations and governance.

Job Overview

• Role: Pharmacovigilance Specialist (Signal Management)
• Experience: 5–8 Years
• Location: Dholka (Near Ahmedabad), Gujarat, India
• Industry: Pharmacovigilance / Drug Safety

Key Responsibilities

1. Pharmacovigilance Compliance

• Maintain and update CAT, Medical Query, and PADER trackers
• Ensure compliance with global pharmacovigilance regulations
• Support accurate documentation and reporting workflows

2. Quality Governance & Audits

• Review and update SOPs (Standard Operating Procedures) and Work Instructions (WIs)
• Assist in internal and external PV audits
• Ensure adherence to quality and regulatory standards

3. PADER & Safety Reporting

• Manage Periodic Adverse Drug Experience Reports (PADER) schedules
• Coordinate data collection and reporting timelines
• Handle regulatory data requests efficiently

4. Medical Information & Communication (MICC)

• Oversee medical inquiry data management
• Ensure effective cross-functional communication
• Maintain high standards of response quality and compliance

Required Qualifications

• Bachelor’s or Master’s degree in Pharmacy / Life Sciences / Medicine
• 5–8 years of experience in pharmacovigilance signal management
• Strong knowledge of:
  • PADER reporting
  • Safety databases and PV systems
  • Regulatory compliance (FDA, EMA guidelines)
• Experience in audit handling and SOP review
• Excellent communication and analytical skills

Preferred Skills

• Exposure to global pharmacovigilance operations
• Hands-on experience with medical inquiry handling (MICC)
• Strong attention to detail in signal detection and risk management

Salary & Benefits

• Estimated Salary: ₹8 – ₹15 LPA (based on experience and expertise)
• Opportunity to work in a regulated PV environment
• Exposure to audit readiness and global safety reporting
• Career growth in signal management and drug safety governance

How to Apply

Interested candidates can apply directly by sending their updated resume to:

📧 Email: savitri.thakor@cadilapharma.com

Tip: Mention “Pharmacovigilance Specialist – Signal Management” in the subject line for faster screening.