Officer Job for Freshers At Lambda Therapeutic | Pharmacy Graduates Apply Now
Lambda Therapeutic Research Ltd. is hiring an Officer – ICSR for its global pharmacovigilance operations in Ahmedabad, Gujarat. This entry-level role is designed for Bachelor’s degree holders in Life Sciences or Pharmacy who are looking to start a career in Individual Case Safety Report (ICSR) processing. The successful candidate will manage end-to-end case processing, including MedDRA coding, narrative writing, and causality assessments, ensuring 100% regulatory compliance for global pharmaceutical clients.
- Job Title: Officer – ICSR
- Req ID: 1432
- Location: Ahmedabad, India
About the Company
Lambda Therapeutic Research Ltd. is a leading global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With a strategic presence in the USA, Canada, UK, Poland, and Spain, Lambda provides comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries. The firm is recognized for its commitment to high-quality scientific standards and regulatory excellence across the drug development lifecycle.
Job Details
- Perform pharmacovigilance case processing, including duplicate search and validation.
- Complete data entry, drug coding, MedDRA coding, listedness, causality assessment, expediting assessment, and narrative writing for ICSRs in accordance with SOPs, WIs, and regulatory guidelines.
- Prepare, revise, and review SOPs, Work Instructions, templates, guides, and training documents.
- Communicate urgent safety issues promptly to the Line Manager and QPPV.
- Maintain professional communication standards and accurate records of internal and external correspondence.
- Ensure compliance with quality standards, procedures, regulations, timelines, and consistency as per local and global PV requirements.
- Deliver training sessions for new joiners and team members as required.
- Collaborate with the ICSR Team Leader to escalate issues beyond normal scope.
- Support the Group Leader in achieving 100% regulatory compliance for timely case processing.
- Provide pharmacovigilance advice to clients and colleagues as needed.
- Assist and mentor less experienced team members to enable them to fulfill their roles effectively.
- Stay updated on regulatory intelligence and implement changes as required.
- Assist in developing SOPs for Lambda’s Pharmacovigilance Department and clients.
- Communicate with clients and/or regulatory agencies when required.
- Perform any other tasks assigned by the Line Manager to meet business needs.
Experience
Fresher
Educational Qualification
Bachelor’s degree in Pharmacy, or related field is requird for Pharmacy Job
CTC Range (INR):
300000 – 500000
