Pharmacovigilance Scientist

Airvin Skills; Hyderabad, Chennai, Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Airvin Skills in India is seeking a Pharmacovigilance professional to collect, assess, and evaluate ADRs and AEs from spontaneous reports, trials, and literature. You will ensure proper case entry and MedDRA coding in safety databases like Argus, contributing to signal detection and risk management.

You will prepare DSURs, PADER, and PSURs, while collaborating with healthcare professionals and regulatory authorities to ensure GxP and PV regulatory compliance.

Qualifications

• Bachelors or Masters in Pharmacy, Pharmacology, Life Sciences, or a healthcare-related field (BSc/B.Pharm/M.Pharm/Pharm.D).
• Strong understanding of medical terminology and the clinical drug development process.
• Prior internship or entry-level experience in pharmacovigilance or clinical research within pharmaceutical companies or CROs is preferred.

Responsibilities

• Collect, assess, and evaluate Adverse Drug Reactions (ADRs) and Adverse Events (AEs) from spontaneous reports, clinical trials, and literature.
• Ensure accurate case entry, verification, and medical coding using MedDRA for serious and non-serious cases in safety databases like Argus.
• Contribute to signal detection, risk assessment, and the development of risk management strategies.
• Prepare, author, and review periodic aggregate safety reports (e.g., DSURs, PADER, PSURs) and safety monitoring plans.
• Collaborate with healthcare professionals, regulatory authorities, and cross-functional teams while ensuring GxP and PV regulatory compliance.

Skills

Medical terminology

Clinical drug development

Communication

PV fundamentals

Education

Bachelor's or Master's in Pharmacy/Pharmacology/Life Sciences/Pharm.D.

Tools

Argus

ArisG

MedDRA

Job description

Key Responsibilities:

• Collect, assess, and evaluate Adverse Drug Reactions (ADRs) and Adverse Events (AEs) from spontaneous reports, clinical trials, and literature.
• Ensure accurate case entry, verification, and medical coding using MedDRA for serious and non-serious cases in safety databases like Argus.
• Contribute to signal detection, risk assessment, and the development of risk management strategies.
• Prepare, author, and review periodic aggregate safety reports (e.g., DSURs, PADER, PSURs) and safety monitoring plans.
• Collaborate with healthcare professionals, regulatory authorities, and cross-functional teams while ensuring GxP and PV regulatory compliance.

Qualifications:

• achelor's or Master's degree in Pharmacy, Pharmacology, Life Sciences, or a healthcare-related field (BSc/B.Pharm/M.Pharm/Pharm.D).
• Strong understanding of medical terminology and the clinical drug development process.
• Prior internship or entry-level experience in pharmacovigilance or clinical research within pharmaceutical companies or CROs is preferred.

Desired Skills:

• Coding & Databases: Proficiency in MedDRA search strategies and safety databases (e.g., Argus, ArisG).
• Regulatory Knowledge: Deep understanding of clinical trial safety regulations and post-marketing PV compliance.
• Analytical Ability: Capability to analyze complex medical data and safety reports to draw accurate clinical conclusions.
• Communication: Excellent verbal and written communication skills for cross-functional and stakeholder collaboration.

What You'll Gain:

• Domain Expertise: Specialized knowledge in pharmacovigilance, drug safety, and global regulatory guidelines.
• Technical Proficiency: Strong hands-on experience with advanced data management, medical coding, and signal detection tools.
• Career Advancement: Rapid progression opportunities into roles like Senior PV Scientist, Medical Writer, or Safety Lead.
• Public Health Impact: Meaningful contribution to global patient safety by identifying drug risks and side effects.