Job Title:  Manager - Medical Reviewer

ORGANISATIONAL OVERVIEW

We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA) and Fargo (USA). Over 1500 employees are working across the globe in these facilities.

Lambda offers Full-spectrum clinical trial solutions empowered by more than 20 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and acommitment to quality to help clients develop products safely, effectively, and quickly.

Delivering the best accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That is why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team.

JOB DETAILS

• Signal detection and management activities: Performing signal detection for client’s medicinal product, to assess benefit risk balance of the client’s medicinal product.
• Interact with signal detection 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 signal detection).
• 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

5 years of Pharmacovigilance experience or relevant signal detection/PSUR experience.

EDUCATIONAL QUALIFICATION

MBBS/MD Pharmacology