Job Title:  Assistant Manager - Medical Reviewer

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

JOB DETAILS

• ICSR activities: Performing ICSR-medical review for client’s medicinal product, to assess benefit causality, SUSAR assessment of the client’s medicinal product.
• Interact with ICSR team at various levels and in various functional areas to resolve any issues that arise during reviews and to use more effective methodologies for improvement of efficiency.
• Providing input into responses to inquiries from regulatory authorities or health care professionals on safety issues and assist in the training team members.
• Literature review for selection of ICSR and article of interest (for ICSR).
• Performs comparison of client’s label with reference/innovator label and to recommend the changes in client’s label.
• Communication of urgent safety issues to Line manager and QPPV.
• Health Hazard assessment report drafting.

EXPERIENCE

2 years of Pharmacovigilance experience or relevant clinical experience.

EDUCATIONAL QUALIFICATION

MBBS/MD Pharmacology