Launch Your Career in Pharmacovigilance
Join a Global Team Protecting Patient Safety
Lambda Therapeutic Research is a premier global Clinical Research Organization (CRO) dedicated to advancing healthcare through meticulous and ethical clinical research. With our headquarters in Ahmedabad and a strategic international presence, we provide end-to-end clinical trial solutions. We are looking for a motivated and detail-oriented graduate to begin a rewarding career in Pharmacovigilance, where you will play a direct role in ensuring drug safety and regulatory compliance worldwide.
Key Responsibilities
Case Processing & Data Management
- Perform pharmacovigilance case processing, including duplicate searches and initial case validation.
- Accurately complete data entry, drug coding (using standard dictionaries), MedDRA coding, listedness assessment, causality evaluation, expediting assessment, and narrative writing for Individual Case Safety Reports (ICSRs).
- Ensure all activities are conducted in strict accordance with SOPs, Work Instructions (WIs), and global regulatory guidelines (ICH-GCP, FDA, EMA).
Documentation & Compliance Support
- Assist in the preparation, revision, and review of Pharmacovigilance documents, including SOPs, Work Instructions, templates, and training materials.
- Help maintain compliance with all quality standards, regulatory requirements, and processing timelines.
- Support the team in achieving 100% regulatory compliance for timely and accurate case processing.
Communication & Collaboration
- Communicate urgent safety findings promptly to the Line Manager and Qualified Person for Pharmacovigilance (QPPV).
- Maintain professional and accurate records of all internal and external correspondence.
- Collaborate with the ICSR Team Leader to escalate issues as needed.
- Assist in client and regulatory communication under guidance.
Training & Continuous Improvement
- Participate in and support training sessions for new team members.
- Stay updated on changes in regulatory intelligence and help implement procedural updates.
- Mentor and support peers under the guidance of senior team members.
Qualifications & Experience
Essential Requirements:
- Bachelor’s degree in Life Sciences, Pharmacy, or a closely related field.
- A strong academic foundation and a keen interest in pharmacovigilance, drug safety, and regulatory affairs.
- Excellent attention to detail, analytical thinking, and written communication skills.
- High level of integrity and a commitment to accuracy and confidentiality.
- Ability to follow detailed procedures and work effectively in a team-oriented environment.
- Proficiency in English (written and spoken).
Ideal Candidate Profile:
- A recent graduate eager to build a specialist career in pharmacovigilance within a global CRO.
- Proactive learner with strong organizational skills and the ability to manage multiple tasks.
- Basic understanding of medical terminology and clinical research principles is beneficial.
Why Begin Your Career at Lambda?
- Foundational Training: Receive comprehensive, structured training in global pharmacovigilance standards and case processing.
- Meaningful Impact: Your work will directly contribute to patient safety and the reliability of medicines used worldwide.
- Global Exposure: Be part of an international pharmacovigilance team, gaining experience with diverse regulatory requirements.
- Career Pathway: Clear progression opportunities from Associate to Senior roles within Pharmacovigilance and Drug Safety.
- Supportive Environment: Learn from experienced professionals in a culture that values mentorship, quality, and professional growth.
Ready to start your professional journey in a critical and growing field?
Apply now for the Pharmacovigilance Associate position at Lambda.
Lambda Therapeutic Research is an equal opportunity employer. We are committed to nurturing early talent and creating an inclusive environment where every team member can grow and contribute to safeguarding public health.
