Job Title: Manager - Medical Review
Ahmedabad, India
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 a commitment 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
▪ Responsible for Medical review of Company and Literature and Regulatory cases
▪ Appropriate selection of adverse events and assessment of seriousness criteria
▪ MedDRA Coding of the adverse events
▪ Review of reporter/company causality and Label assessment
▪ Selection of product role (suspect, concomitant or interacting) and concomitant conditions, medical history, and laboratory data
▪ Case Narrative evaluation
EXPERIENCE
- 3-4 years’ experience in Pharmacovigilance (ICSR domain)
- Excellent medical knowledge and skills
- Experience in signal detection/aggregate report is preferred.
EDUCATIONAL QUALIFICATION
MBBS/MD doctorate in related discipline