The pharmaceutical and clinical research industry is expanding rapidly in India, creating exciting career opportunities for life science and pharmacy graduates. One such opportunity is currently available at Lambda Therapeutic Research Ltd., a globally recognized Clinical Research Organization (CRO).
The company is hiring for the position of Officer – ICSR (Individual Case Safety Report) at its Ahmedabad location. This role is an excellent opportunity for fresh graduates who want to start their career in pharmacovigilance, drug safety, and clinical research.
Professionals working in ICSR roles play an important part in monitoring the safety of medicines and ensuring that adverse drug reactions are properly documented and reported according to global regulatory guidelines.
About Lambda Therapeutic Research 🌍
Lambda Therapeutic Research Ltd. is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The company provides comprehensive clinical research services to pharmaceutical, biotechnology, and generic drug companies worldwide.
Lambda specializes in clinical trials, bioequivalence studies, pharmacovigilance services, and regulatory support.
The organization operates globally with research facilities and offices in multiple locations, including:
- Mehsana, India
- Las Vegas, USA
- Toronto, Canada
- Barcelona, Spain
- London, United Kingdom
- Warsaw, Poland
With its strong international presence, Lambda helps pharmaceutical companies conduct safe and compliant drug development programs.
Job Overview – Officer ICSR 🧑⚕️
- Position: Officer – ICSR
- Company: Lambda Therapeutic Research Ltd.
- Location: Ahmedabad, India
- Experience: Freshers can apply
- Salary Range: ₹3,00,000 – ₹5,00,000 per year
- Industry: Clinical Research / Pharmacovigilance
The Officer – ICSR role focuses on handling Individual Case Safety Reports, which are critical for monitoring the safety of pharmaceutical products during clinical trials and post-marketing phases.
Professionals in this role analyze adverse drug reactions and ensure they are documented and reported according to international regulatory standards.
Key Responsibilities 📋
Candidates selected for this position will be responsible for several pharmacovigilance activities.
Pharmacovigilance Case Processing
- Perform ICSR case processing according to global regulatory guidelines.
- Conduct duplicate search and case validation to ensure accuracy.
Medical Coding and Data Entry
- Perform drug coding and MedDRA coding for safety cases.
- Enter adverse event data into pharmacovigilance databases.
Safety Evaluation
- Conduct causality assessment between drug and adverse event.
- Evaluate listedness and determine regulatory reporting requirements.
Narrative Writing
- Prepare detailed safety narratives describing patient history, treatment, and reported adverse reactions.
Documentation and SOP Management
- Prepare or revise Standard Operating Procedures (SOPs) and work instructions.
- Maintain proper documentation for pharmacovigilance processes.
Communication and Collaboration
- Communicate urgent safety issues to the Line Manager or QPPV.
- Work closely with ICSR Team Leaders and safety teams.
Training Support
- Assist in training new team members and provide support to colleagues.
Regulatory Compliance
- Ensure compliance with pharmacovigilance reporting timelines.
- Stay updated with global safety guidelines and regulatory requirements.
Educational Qualification 🎓
Candidates interested in this role should have one of the following qualifications:
- Bachelor’s degree in Life Sciences
- B.Pharm or Pharmacy-related degree
- Any relevant biomedical or healthcare qualification
Fresh graduates with a strong interest in pharmacovigilance and drug safety are encouraged to apply.
Skills Required for ICSR Roles 💡
To succeed in pharmacovigilance and ICSR processing roles, candidates should develop the following skills:
✔ Basic understanding of pharmacovigilance concepts
✔ Knowledge of MedDRA coding and adverse event reporting
✔ Strong analytical and documentation skills
✔ Good communication and teamwork abilities
✔ Attention to detail in medical data analysis
Knowledge of ICH guidelines and global pharmacovigilance regulations can provide an additional advantage.
Career Growth in Pharmacovigilance 📈
Starting as an ICSR Officer can open several career opportunities within the pharmaceutical and CRO industry.
Professionals can progress to roles such as:
- Drug Safety Associate
- Pharmacovigilance Specialist
- Senior Safety Scientist
- Pharmacovigilance Manager
- Regulatory Affairs Specialist
As global drug safety regulations continue to evolve, the demand for pharmacovigilance professionals is increasing worldwide.
Why Choose a Career in Pharmacovigilance? 🚀
Pharmacovigilance is one of the fastest-growing areas in the pharmaceutical and healthcare industry.
Here are some reasons why many graduates choose this field:
⭐ High demand in pharmaceutical and CRO companies
⭐ Opportunities to work on global clinical research projects
⭐ Strong career growth and specialization options
⭐ Opportunities in regulatory agencies and international companies
Professionals working in pharmacovigilance contribute directly to patient safety and global drug monitoring systems.
Final Thoughts ✨
The Officer – ICSR position at Lambda Therapeutic Research Ltd. offers an excellent entry point for life science and pharmacy graduates who want to start their careers in the pharmacovigilance and clinical research industry.
Freshers interested in drug safety, adverse event reporting, and regulatory compliance can gain valuable hands-on experience in this role while working with a globally recognized CRO.
If you are planning to build a career in pharmacovigilance or clinical research, this opportunity could be the perfect start to your professional journey.
Apply Here 👇
https://careers.lambda-cro.com/job/Ahmedabad-Officer-ICSR/50008144
