Medical Information Specialist

Experience: 2–3 Years
Qualification: B.Pharm / M.Pharm / BDS

Job Overview

We are looking for a dedicated Medical Information Specialist with 2–3 years of experience in medical information, pharmacovigilance, adverse event intake, and product complaint management. The ideal candidate will be responsible for handling medical inquiries, processing adverse events, managing product complaints, and ensuring compliance with global pharmacovigilance regulations and Good Documentation Practices (GDP).

The role requires excellent communication skills, strong attention to detail, and the ability to manage safety information received through multiple communication channels while ensuring timely and accurate documentation.

Key Responsibilities

Medical Information Management

• Receive and process medical information inquiries through phone calls, emails, faxes, mail, and voicemail.
• Update and maintain the Voicemail Tracker accurately.
• Respond to customer inquiries using approved FAQs and product labeling.
• Create and manage inquiry records in IRMS.
• Generate reports related to medical information inquiries.

Pharmacovigilance & Safety Case Processing

• Receive and process adverse event (AE) reports from various communication channels.
• Perform initial case triage and book safety cases into the ARIS-g safety database.
• Complete Adverse Event Management (AEM) forms following Good Documentation Practices (GDP).
• Attach relevant source documentation and supporting files to safety cases.
• Ensure timely and accurate safety reporting in accordance with regulatory requirements.

Product Complaint Handling

• Receive and manage product complaints through TrackWise.
• Attach Product Replacement Authorization Forms whenever applicable.
• Follow TrackWise conventions while documenting and managing product complaints.
• Maintain accurate complaint records and supporting documentation.

Documentation & Data Management

• Enter relevant information received through phone calls, emails, faxes, and mail into IRMS.
• Record significant and non-significant communications for reconciliation and internal tracking.
• Maintain complete, accurate, and compliant documentation.
• Ensure data integrity across all pharmacovigilance systems.

Regulatory Compliance

• Ensure compliance with global pharmacovigilance regulations and company SOPs.
• Maintain Good Documentation Practices (GDP) throughout all activities.
• Support internal audits and quality initiatives.
• Handle confidential medical and safety information with accuracy and professionalism.

Required Qualifications

• B.Pharm
• M.Pharm
• BDS

Experience Required

• 2–3 years of experience in Medical Information, Pharmacovigilance, Drug Safety, or Adverse Event Processing.
• Hands-on experience with TrackWise, IRMS, and ARIS-g is preferred.
• Good understanding of pharmacovigilance processes and regulatory requirements for safety reporting.

Required Skills

• Medical Information
• Pharmacovigilance
• Adverse Event Processing
• Drug Safety
• Product Complaint Management
• TrackWise
• IRMS
• ARIS-g
• Case Triage
• Good Documentation Practices (GDP)
• Regulatory Compliance
• Medical Documentation
• Customer Communication
• Data Management
• Attention to Detail

Why Join Us?

• Opportunity to work in a global medical information and pharmacovigilance environment.
• Exposure to international regulatory and drug safety processes.
• Collaborative workplace with continuous learning and career development opportunities.
• Contribute to improving patient safety through high-quality medical information and pharmacovigilance practices.