Clinical Research Jobs at Immuneel Therapeutics
Are you searching for Clinical Research Jobs in India’s rapidly growing biotechnology sector? Immuneel Therapeutics Jobs presents an exciting opportunity for aspiring professionals to begin their career as Clinical Development & Medical Affairs Trainee. This full-time position offers hands-on exposure to pharmacovigilance, clinical safety, regulatory compliance, and post-market surveillance, making it an excellent opportunity for life science graduates who want to build a future in clinical research and advanced cell & gene therapy.
About the Company
Immuneel Therapeutics Pvt. Ltd. is a pioneering Indian biotechnology company dedicated to developing personalised immunotherapy and advanced cell and gene therapies. The organisation focuses on engineered cell therapies, including CAR-T technology, to deliver innovative treatment options for patients. Through research, clinical development, and regulatory excellence, Immuneel Therapeutics Jobs provide professionals with opportunities to contribute to cutting-edge healthcare innovations while building rewarding careers in biotechnology and clinical research.
Job Details:
- Job Title: Trainee – Clinical Development & Medical Affairs
- Company: Immuneel Therapeutics Pvt. Ltd.
- Location: Bengaluru, Karnataka, India
- Department: Medical Affairs
- Employment Type: Full-Time, Onsite
About the Role
The Trainee – Clinical Development & Medical Affairs will support post-approval safety monitoring activities for Advanced Therapy Medicinal Products (ATMPs), including CAR-T cell and gene therapies. The role offers structured training and practical exposure to pharmacovigilance, safety reporting, regulatory compliance, and post-market surveillance activities.
Key Responsibilities
- Assist in the collection, review, and documentation of post-market efficacy and safety data, including Adverse Events (AEs) and Serious Adverse Events (SAEs).
- Support real-world data generation and maintenance of case record forms, including safety case records in pharmacovigilance databases under supervision.
- Perform data collection, data entry, identification of data gaps, data analysis, and outcome assessments.
- Assist in tracking therapy-specific safety events, including:
- Cytokine Release Syndrome (CRS)
- Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
- Infections
- Other known CAR-T and Cell & Gene Therapy (CGT) safety risks
- Support the preparation of:
- Post-Market Surveillance Reports (PMSR)
- Periodic Safety Update Reports (PSUR/PBRER)
- Long-Term Follow-Up (LTFU) safety documentation
- Assist in maintaining post-market surveillance documentation in compliance with internal Standard Operating Procedures (SOPs).
- Participate in internal training programs related to pharmacovigilance, cell and gene therapy products, and regulatory compliance.
- Assist in SOP reviews and documentation updates as assigned.
Primary Objectives
- Ensure compliance with regulatory requirements for Post-Market Surveillance (PMS).
- Support signal detection and safety reporting activities.
Educational Qualification
Candidates should possess a Bachelor’s or Master’s degree in one of the following disciplines:
- Life Sciences
- Biotechnology
- Biomedical Sciences
- Related disciplines
Preferred Qualification
Preference will be given to candidates with specialization or coursework in:
- Oncology
- Immunology
- Gene Therapy
- Pharmacovigilance
Required Skills & Competencies
Technical Competencies
- Basic understanding of pharmacovigilance and drug safety concepts.
- Strong attention to detail and documentation skills.
- Good written and verbal communication skills.
- Willingness to learn advanced therapy platforms and evolving regulatory standards.
- Ability to work collaboratively in a regulated environment.
Soft Skills
- Attention to detail
- Time management
- Communication skills
- Cross-functional collaboration
- Accountability
- Compliance with SOPs and applicable guidelines
- Analytical thinking
- Learning agility
- Willingness to learn
- Continuous learning mindset
Reporting Structure
- Reports To: Medical Affairs
- Direct Reports: Individual Contributor
Working Conditions
- Role Type: Full-Time, Onsite
- Work Schedule:
General Shift: 9:00 AM – 6:00 PM
Post-Noon Shift: 2:00 PM – 11:00 PM (Rotational)
Two weekly offs, which may not necessarily fall on Saturday or Sunday. - Travel Requirement: Approximately 10%
- Work Location: Immuneel Therapeutics Pvt. Ltd., 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bengaluru – 560099.
