Lambda Therapeutic Research Hiring Officer – ICSR (Pharmacovigilance)

Lambda Therapeutic Research Hiring Officer – ICSR (Pharmacovigilance) in Ahmedabad | Freshers Eligible | ₹3–5 LPA

Lambda Therapeutic Research Ltd. is hiring for the position of Officer – ICSR in Ahmedabad, India. This is a full-time pharmacovigilance opportunity open to freshers with a Bachelor’s degree in Life Sciences or Pharmacy. The role is part of the company’s global drug safety operations team and focuses on ICSR processing, MedDRA coding, narrative writing, regulatory compliance, and case validation in alignment with international pharmacovigilance standards. The offered CTC range is ₹3,00,000 to ₹5,00,000 per annum, making it a strong entry-level opportunity for candidates seeking careers in drug safety and regulatory operations.

This position is ideal for candidates aiming to build expertise in Individual Case Safety Report (ICSR) processing, global pharmacovigilance compliance, and safety database management within a multinational Clinical Research Organization (CRO).

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Company Overview

Lambda Therapeutic Research is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The organization delivers comprehensive end-to-end clinical research and pharmacovigilance services to innovator, biotech, and generic pharmaceutical companies worldwide.

With operational facilities in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), Lambda has established itself as a trusted global partner in clinical development, bioequivalence studies, regulatory submissions, and drug safety operations. The company operates under strict compliance with international regulatory standards including FDA, EMA, and ICH guidelines.

Working at Lambda provides exposure to global safety reporting systems, validated pharmacovigilance processes, and structured quality management systems in a compliance-driven CRO environment.

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Job Role & Responsibilities

The Officer – ICSR will be responsible for performing pharmacovigilance case processing activities in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), and global regulatory requirements.

ICSR Case Processing

• Perform duplicate search and case validation in safety databases
• Complete accurate data entry for Individual Case Safety Reports
• Conduct drug coding and MedDRA coding
• Assess listedness and causality as per regulatory guidelines
• Perform expediting assessment to ensure timely reporting
• Draft clear and compliant case narratives

Regulatory Compliance & Documentation

• Ensure adherence to local and global pharmacovigilance requirements
• Maintain compliance with timelines and quality standards
• Support 100% regulatory compliance for timely case processing
• Maintain accurate records of internal and external correspondence

SOP Development & Quality Systems

• Assist in preparation and revision of SOPs, work instructions, templates, and guides
• Contribute to development of pharmacovigilance documentation for clients
• Stay updated with regulatory intelligence and implement changes as required

Communication & Escalation

• Communicate urgent safety issues promptly to Line Manager and QPPV
• Coordinate with ICSR Team Leader for escalation of complex issues
• Communicate with clients and regulatory agencies when required

Training & Mentorship

• Deliver training sessions for new joiners and team members
• Assist and mentor junior colleagues in pharmacovigilance processes

Additional Responsibilities

• Support the Group Leader in achieving operational excellence
• Participate in audits and inspection readiness activities
• Perform any other PV-related tasks as assigned by management

This role builds a strong foundation in pharmacovigilance operations and prepares candidates for future growth into roles such as Drug Safety Associate, PV Specialist, or Safety Reviewer.

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Eligibility / Qualifications

This opportunity is open to fresh graduates seeking entry into pharmacovigilance and clinical research operations.

Educational Qualification

Bachelor’s degree in Life Sciences, Pharmacy, Pharmaceutical Sciences, Biotechnology, Microbiology, Biochemistry, or related healthcare discipline

Experience Requirement

• Fresher candidates are eligible to apply
• Basic understanding of pharmacovigilance concepts is an advantage

Required Skills

• Knowledge of medical terminology and drug safety concepts
• Strong attention to detail
• Good analytical and problem-solving skills
• Effective written and verbal communication
• Ability to meet strict regulatory timelines

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Location & Salary

Job Title: Officer – ICSR
Location: Ahmedabad, India
Employment Type: Full-Time
CTC Range: ₹3,00,000 – ₹5,00,000 per annum

Compensation will be offered based on qualification, assessment, and company policies. The role offers long-term career growth in global pharmacovigilance and regulatory compliance.

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Application Process

Interested and eligible candidates can apply through the official Lambda Therapeutic Research career portal using the link below:

https://careers.lambda-cro.com/job/Ahmedabad-Officer-ICSR/50008144/

Early application is recommended as positions may close once suitable candidates are identified.

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Frequently Asked Questions (FAQs)

Who can apply for the Officer – ICSR role at Lambda?
Fresh graduates with a Bachelor’s degree in Life Sciences or Pharmacy are eligible.

Is prior pharmacovigilance experience required?
No. This is a fresher-level opportunity.

What salary is offered for this position?
The CTC range is ₹3 to ₹5 LPA.

What skills will I develop in this role?
You will gain expertise in ICSR processing, MedDRA coding, narrative writing, regulatory compliance, and global drug safety standards.

Is this role part of a CRO?
Yes. Lambda Therapeutic Research is a global Clinical Research Organization.

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Summary Table

Company	Lambda Therapeutic Research Ltd.
Vacancies	Officer – ICSR
Required Education	Bachelor’s in Life Sciences, Pharmacy
Experience	Fresher

Tagged as: Pharma Jobs in Ahmedabad