Pharmacovigilance ICSR Intern (Full-Time)
Job Title: Pharmacovigilance ICSR Intern (Full-Time)
Location: Hyderabad, Telangana
Job Type: Full-Time
Department: Pharmacovigilance
Experience: Freshers
Education: B.Pharm, Pharm.D, M.Pharm
About Us
We are a fast-growing global Pharmacovigilance and Regulatory Services organization committed to delivering high-quality drug safety and regulatory solutions to pharmaceutical, biotechnology, and medical device companies worldwide. We are looking for enthusiastic life science graduates who are passionate about Drug Safety and Pharmacovigilance to join our growing Pharmacovigilance team.
Job Summary
The Pharmacovigilance ICSR Intern will receive structured training in Individual Case Safety Report (ICSR) processing and global pharmacovigilance regulations. The intern will work closely with experienced Pharmacovigilance professionals and gain hands-on experience in adverse event case processing using industry-standard safety databases and regulatory guidelines.
This internship is designed as a full-time employment opportunity with excellent career growth in Pharmacovigilance.
Key Responsibilities
- Receive comprehensive training in Pharmacovigilance and ICSR processing.
- Review adverse event reports received from multiple sources.
- Perform case intake and triage.
- Enter safety data into Pharmacovigilance databases.
- Code adverse events using MedDRA.
- Code medicinal products using WHO Drug Dictionary (training provided).
- Assess case validity according to ICH guidelines.
- Prepare accurate and complete Individual Case Safety Reports (ICSRs).
- Perform literature screening support activities (where applicable).
- Assist in follow-up request management.
- Maintain compliance with SOPs, Work Instructions, and global regulatory requirements.
- Ensure data quality and completeness.
- Participate in quality review activities under supervision.
- Maintain confidentiality of patient safety information.
- Complete assigned training modules within timelines.
Eligibility
Required Qualifications
- Bachelor's or Master's degree in:
- Pharmacy
- Pharm.D
Fresh graduates are encouraged to apply.
Preferred Skills
- Basic understanding of Pharmacovigilance.
- Knowledge of Adverse Drug Reactions (ADR).
- Good written and verbal communication skills.
- Strong analytical skills.
- Good attention to detail.
- Basic knowledge of MS Office (Excel, Word, PowerPoint).
- Ability to work in a team environment.
- Willingness to learn global drug safety regulations.
Training Provided
Selected candidates will receive structured training on:
- Introduction to Pharmacovigilance
- ICSR Case Processing
- MedDRA Coding
- WHO Drug Dictionary
- Seriousness Assessment
- Expectedness Assessment
- Causality Basics
- Literature Case Processing
- Follow-up Management
- Global Regulatory Reporting
- ICH Guidelines (E2A, E2B(R3), E2D)
- FDA, EMA, MHRA Pharmacovigilance Requirements
- Good Documentation Practices (GDP)
- Data Privacy and Compliance
- Industry Safety Databases (training exposure)
Desired Competencies
- Positive attitude
- Quick learner
- Problem-solving ability
- High level of integrity
- Strong organizational skills
- Time management
- Professional communication
- Adaptability
Career Growth
Successful candidates will have opportunities to grow into roles such as:
- Drug Safety Associate
- Pharmacovigilance Associate
- ICSR Case Processor
- Drug Safety Specialist
- Senior Drug Safety Associate
- Quality Reviewer
- Team Lead
- Pharmacovigilance Scientist
What We Offer
- Full-time employment
- Comprehensive Pharmacovigilance training
- Hands-on industry experience
- Mentorship from experienced PV professionals
- Career development opportunities
- Exposure to global Pharmacovigilance projects
- Performance-based career progression
- Collaborative and learning-focused work environment
Preferred Candidate Profile
- Passionate about building a career in Pharmacovigilance.
- Strong commitment to quality and patient safety.
- Excellent communication and documentation skills.
- Ability to work independently and collaboratively.
- Ready to join immediately or within a short notice period.
How to Apply
Interested candidates are invited to submit their updated resume.
Application Question:
- Are you available to work full-time?
- What is your highest qualification?
- Are you willing to undergo Pharmacovigilance ICSR training?
- What is your current location?
- Are you available to join immediately?
Indeed Keywords (ATS Optimized)
Pharmacovigilance, Drug Safety, ICSR, Individual Case Safety Report, Drug Safety Associate, PV Associate, MedDRA, WHO Drug Dictionary, Case Processing, Adverse Events, ADR, Pharmacovigilance Internship, Life Sciences, Pharmacy, PharmD, Medical Coding, Drug Safety Internship, Regulatory Affairs, Clinical Research, Entry Level Pharmacovigilance, Freshers Jobs, Pharma Jobs, Healthcare Jobs.
Pay: From ₹12,000.00 per month
Benefits:
Work Location: In person
