ICON is hiring for three full-time positions in India across Pharmacovigilance, Medical Coding, and Trial Master File (TMF) management. The openings are based in Chennai, Bangalore, and Trivandrum, with office, home, or hybrid work arrangements depending on the role.
Job Details
| Position | Location | Work Mode | Experience |
|---|---|---|---|
| Pharmacovigilance Reporting Associate (Submission) | Chennai, Bangalore | Office or Home | Experience in pharmacovigilance or drug safety |
| Medical Coding Specialist I – Hybrid | Chennai, Trivandrum | Office With Flex | Proven medical coding experience |
| TMF Specialist (All Levels) | Chennai | Office With Flex | Minimum 3 years in clinical research or TMF management |
Company: ICON
Employment Type: Full Time
Job Locations: Chennai, Bangalore, Trivandrum, India
1. Pharmacovigilance Reporting Associate (Submission)
Responsibilities
- Prepare and review safety reports, including periodic safety updates and individual case safety reports.
- Collect and analyze adverse event data from clinical trials and post-marketing sources.
- Maintain knowledge of pharmacovigilance reporting regulations and industry best practices.
- Collaborate with clinical, regulatory, and data management teams.
- Ensure timely submission of safety reports to regulatory authorities and sponsors.
Eligibility & Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
- Experience in pharmacovigilance or drug safety.
- Strong understanding of safety reporting processes and regulatory requirements.
- Ability to manage multiple tasks and prioritize work in a regulated environment.
- Willingness to travel approximately 10%.
Required Skills
- Safety report preparation and review
- Pharmacovigilance and drug safety
- Adverse event data analysis
- Regulatory compliance
- Attention to detail
- Communication and collaboration
- Organizational and time-management skills
2. Medical Coding Specialist I – Hybrid
Responsibilities
- Perform advanced medical coding of diagnoses, procedures, and medications.
- Use coding systems such as MedDRA and WHO Drug.
- Ensure coding accuracy, consistency, and regulatory compliance across clinical studies.
- Work with clinical and data management teams to resolve coding discrepancies and queries.
- Support the development and refinement of medical coding conventions and procedures.
- Stay updated on changes to medical coding standards.
Eligibility & Qualifications
- Bachelor’s degree in Life Sciences, Healthcare, or a related field.
- Proven experience in medical coding, preferably using MedDRA and WHO Drug.
- Experience within a clinical research setting.
- Strong understanding of clinical trial processes and medical coding requirements.
Required Skills
- MedDRA
- WHO Drug
- Medical coding
- Clinical trial processes
- Problem-solving
- Accuracy and attention to detail
- Cross-functional collaboration
3. TMF Specialist (All Levels)
Responsibilities
- Manage and maintain the Trial Master File (TMF) for assigned clinical trials.
- Ensure completeness, accuracy, and quality of TMF documents throughout the trial lifecycle.
- Collaborate with study teams for timely collection, processing, and filing of essential documents.
- Conduct TMF audits and inspections.
- Support and guide internal stakeholders on TMF-related matters.
Eligibility & Qualifications
- Bachelor’s degree in Life Sciences, Documentation Management, or a related discipline.
- Minimum 3 years of experience in clinical research or TMF management.
- Strong understanding of TMF regulations, guidelines, and best practices.
- Proficiency in electronic document management systems and TMF software.
Required Skills
- Trial Master File management
- Clinical research
- TMF regulations and guidelines
- Electronic document management systems
- TMF software
- Documentation management
- Organization and attention to detail
- Communication skills
Application Details
Apply for Pharmacovigilance Reporting Associate
Apply for Medical Coding Specialist I
Apply for TMF Specialist