Clinical / Pharma QA Associate

Airvin Skills; Hyderabad, Chennai, Bengaluru; Hybrid; INR 900,000 - 1,200,000; Full time

Job summary

Airvin Skills is seeking a Pharmacovigilance professional to conduct continuous surveillance of clinical trial data, ensuring data integrity and patient safety. You will identify, track, and evaluate AEs/SAEs in safety databases and perform signal detection using PV and EDC platforms.

You will collaborate with CDM teams to resolve data queries, ensure adherence to ICH-GCP guidelines, and prepare safety summaries and narratives for cross-functional teams.

Qualifications

• Masters in Pharmacy, Pharmacology, Biotechnology, or Life Sciences.
• Strong foundational knowledge of pharmacovigilance, drug safety monitoring, and clinical data management.
• Familiarity with EDC systems, medical terminology, and clinical trial processes.
• Highly analytical mindset with exceptional attention to detail when reviewing large datasets.
• Strong communication and problem-solving skills to work within cross-functional clinical teams.

Responsibilities

• Conduct continuous surveillance and review of clinical trial data to ensure data integrity, accuracy, and patient safety.
• Identify, track, and evaluate adverse events (AEs) and serious adverse events (SAEs) in clinical safety databases.
• Perform signal detection and trend analysis on safety data using PV and EDC platforms.
• Ensure accurate medical coding using MedDRA and WHO-DD.
• Collaborate with CDM teams to generate, track, and resolve data queries and discrepancies.
• Ensure all data surveillance and reporting activities comply with ICH-GCP guidelines and global regulatory standards.
• Prepare and review safety data summaries, patient narratives, and compliance reports for cross-functional teams.

Skills

Pharmacovigilance

Data review

AE/SAE tracking

Medical coding

Regulatory compliance

Cross-functional teamwork

Education

Masters in Pharmacy

Tools

EDC systems

MedDRA

WHO-DD

Job description

Role & responsibilities

• Conduct continuous surveillance and review of clinical trial data to ensure data integrity, accuracy, and patient safety.
• Identify, track, and evaluate adverse events (AEs) and serious adverse events (SAEs) in clinical safety databases.
• Perform signal detection and trend analysis on safety data using specialized Pharmacovigilance (PV) and EDC (Electronic Data Capture) platforms.
• Ensure accurate medical coding of clinical data using industry-standard dictionaries such as MedDRA and WHO-DD.
• Collaborate closely with Clinical Data Management (CDM) teams to generate, track, and resolve data queries and discrepancies.
• Ensure all data surveillance and reporting activities strictly comply with ICH-GCP guidelines and global regulatory standards.
• Prepare and review safety data summaries, patient narratives, and compliance reports for cross-functional teams.

Preferred candidate profile

• Masters degree in Pharmacy (M.Pharm), Pharmacology, Biotechnology, or Life Sciences.
• Strong foundational knowledge of pharmacovigilance, drug safety monitoring, and clinical data management (CDM).
• Familiarity with EDC systems, medical terminology, and clinical trial processes.
• Highly analytical mindset with exceptional attention to detail when reviewing large and complex medical datasets.
• Strong communication and problem-solving skills to work effectively within cross-functional clinical teams.