Pharmacovigilance Specialist

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd is seeking a Pharmacovigilance Case Processor to manage daily adverse event cases. The role involves MedDRA coding, seriousness and expectedness assessment, and creating case narratives to support regulatory submissions.

The candidate should have a Bachelor's in life sciences and around two years of related experience; a higher degree or clinical qualifications are a plus. The position is based in Hyderabad with opportunities to contribute to training materials and

Qualifications

• Bachelor's degree in life sciences required.
• Advanced degree, RN, RPh, PharmD or equivalent preferred.
• Two years of related work experience.

Responsibilities

• Responsible for daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level.
• Perform case follow up activities such as identification of information to be collected during follow-up.
• Creating and reviewing case narratives.
• Providing client notifications as required for case management.
• Supporting and contributing to the development of training materials and training delivery.
• Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRS.
• Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
• Peer reviews of cases for quality, consistency, and accuracy as needed.
• Other duties as assigned

Education

Bachelor's degree in life sciences

Job description

Responsibilities

• Responsible for daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level.
• Perform case follow up activities such as identification of information to be collected during follow-up.
• Creating and reviewing case narratives.
• Providing client notifications as required for case management.
• Supporting and contributing to the development of training materials and training delivery.
• Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRS.
• Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
• Peer reviews of cases for quality, consistency, and accuracy as needed.
• Other duties as assigned

Qualification & Experience

• Required: a Bachelor's degree in life sciences.
• Preferred: advanced degree, RN, RPh, PharmD or equivalent.
• Two years of related work experience.