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

• The role involves ensuring that all pharmacovigilance activities are conducted in compliance with SOPs, global regulations, and industry guidelines.
• It includes providing expert medical and regulatory guidance to clients and internal teams, supporting the assessment and oversight of safety data, and contributing to the continuous improvement of pharmacovigilance processes through the development and revision of SOPs, templates, and training materials.
• The position also entails mentoring junior staff, delivering training, and providing backup medical support as needed.
• Responsibilities include evaluating adverse events, performing causality assessments, reviewing narratives, and ensuring timely and compliant ICSR submissions.
• Effective communication, regulatory intelligence, and collaboration with leadership for issue escalation and regulatory responses are also key aspects of the role.

EXPERIENCE

Clinical experience of 2 years or relevant Pharmacovigilance experience.

EDUCATIONAL QUALIFICATION

MBBS