Lambda Therapeutic Research is a global leader in pharmacovigilance, offering end-to-end drug safety solutions. With over 160 skilled professionals, Lambda supports more than 265 clinical trials across diverse therapeutic areas, focusing on compliance with regulatory standards. Their advanced technology and robust frameworks ensure effective safety monitoring, making them a trusted name in the pharmaceutical industry.
Responsibilities in the Role
As an Officer – Literature Screening, you will play a pivotal role in the pharmacovigilance framework, contributing to the safety monitoring of medicinal products. Your responsibilities include:
- Literature Review: Analyze global scientific and medical literature following company SOPs and regulations.
- Record Maintenance: Keep organized records of all safety reports.
- Documentation: Prepare, revise, and review SOPs, work instructions, guides, and training documents.
- Safety Issues: Report urgent safety concerns to the Line Manager.
- Case Processing: Manage data entry, drug coding, MedDRA coding, narrative writing, and listedness assessment for literature cases.
- Database Management: Create and track safety IDs, conduct duplicate searches, and maintain reconciliation with regulatory sources.
- Communication: Ensure high standards in internal and external communications.
Qualifications Required
To excel in this role, candidates should have the following educational background:
- Degrees: B. Pharm, M. Pharm, or Pharm D (preferably in Pharmacology).
- Additional Certification: Pharmacovigilance Certification Course (preferred but not mandatory).
Skills and Competencies
Lambda values candidates who bring a combination of technical expertise and interpersonal skills. Desired attributes include:
- Strong accountability and work ethic.
- Excellent communication and presentation skills.
- Proficiency in database management and regulatory case handling.
- Flexibility, planning, and organizational skills.
- Leadership qualities and initiative.
- Adaptability to Lambda’s organizational culture.