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ICON Hiring CRA II & Pharmacovigilance Specialists (Bangalore, Chennai & Trivandrum)
Are you seeking ICON Careers India, a Clinical Research Associate Job, or Drug Safety Careers in Bangalore? Global healthcare intelligence and clinical research organization (CRO) ICON plc has announced exciting vacancies across two major operational teams.
These clinical monitoring site visits, PSUR drafting, and adverse event coding vacancies operate under remote and hybrid work models in Bangalore, Chennai, and Trivandrum. The positions are open to experienced life sciences, pharmacy, nursing, or medical graduates. ICON is hiring for **Clinical Research Associate II (CRA II)** and **Pharmacovigilance Reporting Specialist**. Candidates will audit trial documentation (TMF), perform site monitoring operations, and draft Periodic Safety Update Reports (PSUR). To format a resume describing your site visit checklists, ICSR case timelines, or safety database queries, read our guidelines on how to apply for healthcare and pharma jobs online.
📋 Position Details
| Position | Location | Work Mode | Experience | Qualifications |
|---|---|---|---|---|
| Clinical Research Associate II (CRA II) | Bangalore, Chennai, Trivandrum | Remote (With travel) | Minimum 2 Years as CRA | B.Pharm, Life Sciences, Nursing |
| Pharmacovigilance Reporting Specialist | Bangalore, Chennai, Trivandrum | Hybrid | Relevant PV / Safety Experience | B.Pharm, Pharm.D, Life Sciences, Medicine |
💼 Key Responsibilities by Position
1. Clinical Research Associate II (CRA II)
- Site Management: Conduct site qualification, initiation, routine monitoring, and site close-out visits.
- GCP Compliance: Verify study conduct meets study protocols, local regulations, and ICH-GCP guidelines.
- Data Validation: Review electronic Case Report Forms (eCRF) and resolve query backlogs with site coordinators.
- Documentation: Maintain inspection-ready records within Clinical Trial Management Systems (CTMS) and eTMF.
- Travel Operations: Travel frequently to manage up to 8–9 on-site monitoring visits per month (up to 60% travel).
2. Pharmacovigilance Reporting Specialist
- Report Preparation: Prepare and submit Periodic Safety Update Reports (PSURs) and Individual Case Safety Reports (ICSRs).
- Safety Analysis: Review adverse event statistics to evaluate clinical product safety profiles.
- Regulatory Compliance: Ensure reporting timelines align with global pharmacovigilance regulations.
- Medical Writing: Write safety summaries, document safety query outcomes, and support audit preparation.
To learn how clinical operations and pharmacovigilance specialist salaries compare to conventional data coding and statistics careers, read our report on Pharmacovigilance Salary: India vs USA.
🎓 Required Qualifications & Skills
- Education: Bachelor's or Master's degree in Pharmacy (B.Pharm/M.Pharm/Pharm.D), BSc/MSc Life Sciences, Biotechnology, Nursing, or Medicine.
- CRA II Experience: Minimum 2 years of active CRA experience with a track record of independent on-site monitoring.
- PV Experience: Relevant experience in drug safety, narrative writing, signal detection, and PSUR/ICSR processing.
- GCP Standards: Comprehensive knowledge of global FDA, EMA, and ICH-GCP guidelines.
- Communication: Fluent in English with strong interpersonal and stakeholder coordination skills.
For pharmacy and biological science graduates evaluating clinical trial coordination careers compared to conventional laboratory quality control or industrial formulation careers, read our analysis on B.Pharm Careers after Graduation: India vs USA.
🎁 Why Join ICON plc?
- Work for a global leader supporting biotech, pharmaceutical, and medical device trials.
- Diverse career growth paths across global clinical operations and pharmacovigilance structures.
- Flexible remote working options for CRAs alongside hybrid office structures for PV analysts.
- Comprehensive medical insurance, paid leaves, and wellness support programs.
To review your basic knowledge of patient registries, clinical billing, and GCP guidelines before your screening assessments, try our interactive Clinical Trial Assistant (CTA) Quiz.
💡 Clinical Operations vs Healthcare IT
ICON CRA and Drug Safety Specialists manage clinical sites, audit safety datasets, and write safety reports, whereas Healthcare IT professionals support software deployments. To explore these differences, read our comparison on Healthcare IT vs Clinical Healthcare.
📝 Resume Tips for ICON Candidates
- CRA Candidates: Detail your average monthly site visit rate and therapeutic study focus areas (e.g., Oncology, Cardiology).
- PV Candidates: Highlight the specific safety databases (like Argus Safety) and reporting templates you can format.
- Specify Guidelines: Detail your practical application of GCP, FDA, and local CDSCO guidelines.
💬 ICON Selection Interview Questions
- Q1. How do you handle an investigator who is consistently behind on eCRF data entry?
Answer Guidance: I discuss the delay during monitoring visits, highlight protocol deadlines, identify administrative bottlenecks, help resolve query backlogs, and document a corrective action plan in the follow-up report. - Q2. What is the difference between a Periodic Safety Update Report (PSUR) and an ICSR?
Answer Guidance: An ICSR represents an individual safety case report detailing a specific patient adverse event. A PSUR is a cumulative, aggregate safety document evaluating the global benefit-risk profile of a marketed product over a defined time interval. - Q3. What is the main objective of a Site Close-Out Visit (COV)?
Answer Guidance: The COV ensures all trial procedures are completed, investigator files are archived, investigational products are reconciled/returned, and outstanding data queries are resolved.
📖 How to Apply?
Before submitting your application, please read the step-by-step guidance on how to navigate the registration portal, fill out required forms, and format your application profile:
📄 Premium ATS Resume Builder Service
Want to build a professional ATS-friendly resume tailored for Clinical Site Monitoring, Drug Safety Reporting, or Clinical Operations roles? Message us directly on our LinkedIn Company Page with the phrase "I want Resume Builder Service", and our expert team will connect with you:
📲 Message Us on LinkedIn🚀 Direct Application Links
If you are ready with your documents, submit your application directly via the official ICON recruitment links below:
Apply Online – Clinical Research Associate II (CRA II) Apply Online – Pharmacovigilance Reporting Specialist❓ Frequently Asked Questions
Q. Is the CRA II position fully remote?
Yes, it is remote, but it requires up to 60% travel for on-site monitoring visits.
Q. What is the work model for the Pharmacovigilance position?
The Pharmacovigilance Reporting Specialist position is a Hybrid role based out of Bangalore, Chennai, or Trivandrum.
Q. How much experience is required for the CRA II role?
ICON plc requires a minimum of 2 years of active experience working as a Clinical Research Associate.
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