Drug Safety Associate / Pharmacovigilance Executive

Why This Role Matters
This role plays a critical part in ensuring patient safety by monitoring, evaluating, and reporting adverse drug reactions. As part of global pharmacovigilance operations, you contribute to maintaining the safe use of medicines and compliance with international regulatory standards. Your work directly impacts healthcare decisions, risk management, and overall drug safety surveillance.

Job Description
The Associate Safety Data Management Specialist is responsible for handling Individual Case Safety Reports (ICSRs), evaluating adverse event data, and ensuring accurate documentation and regulatory compliance. The role involves working in a structured pharmacovigilance environment, collaborating with cross-functional teams, and supporting global safety and regulatory strategies.

Key Features of the Role:
• Exposure to global pharmacovigilance systems and regulatory frameworks
• Hands-on experience with ICSR processing and safety databases like ARGUS
• Opportunity to work on clinical trial and post-marketing safety data
• Involvement in medical review, data analysis, and regulatory submissions
• Collaborative work environment with medical, regulatory, and safety teams

Responsibilities
• Monitor drug, biologics, and medical device safety surveillance programs
• Intake, evaluate, and process adverse event reports from various sources
• Perform ICSR case processing including data entry, coding, and validation
• Assess case validity, seriousness, causality, and listedness
• Conduct duplicate checks and ensure accurate case prioritization
• Draft and review case narratives for regulatory submissions
• Determine appropriate workflows for case handling and processing
• Perform follow-ups for missing or additional safety information
• Review processed cases to ensure accuracy, completeness, and compliance
• Support regulatory submissions by ensuring adherence to global guidelines
• Analyze post-marketing safety data and medical literature
• Collaborate with internal teams for data reconciliation and reporting
• Maintain compliance with company SOPs and global pharmacovigilance regulations

Required Qualifications
• Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm / Pharm.D)
• Basic understanding of pharmacovigilance and drug safety processes
• Knowledge of medical terminology and adverse event reporting
• Familiarity with global safety regulations and compliance standards

Educational Requirements:
• B.Pharm / M.Pharm / Pharm.D (Mandatory)

Experience and Skills:
• 0–2 years of experience in pharmacovigilance or drug safety
• Knowledge of ICSR processing and case handling workflows
• Familiarity with ARGUS safety database (preferred)
• Understanding of XML formats (E2B R2/R3) is an added advantage
• Strong attention to detail and data accuracy skills
• Good communication and documentation abilities
• Ability to work in a structured, process-driven environment
• Team collaboration and problem-solving skills

Salary Insights
• Expected salary range: ₹3 LPA – ₹6 LPA (approx., based on experience and company standards)

Company Overview
Pfizer is a leading global pharmaceutical organization focused on innovation, drug safety, and improving patient outcomes. With a strong presence in medical and safety operations, the company plays a key role in advancing healthcare through evidence-based medicine and regulatory excellence.

FAQs
• Is prior pharmacovigilance experience mandatory?
No, freshers with relevant knowledge can apply, though experience is preferred.

• What tools are commonly used in this role?
ARGUS safety database, XML-based reporting systems, and medical literature databases.

• Is this a clinical or non-clinical role?
This is a non-clinical role focused on drug safety and regulatory processes.

• What is the career growth path?
Drug Safety Associate → Senior PV Associate → Drug Safety Scientist → PV Manager

Application Tips
• Highlight knowledge of pharmacovigilance and ICSR processing in your CV
• Mention any experience with ARGUS or safety databases
• Emphasize attention to detail and documentation skills
• Include certifications or training in drug safety (if any)
• Prepare for interview questions on adverse event reporting and case processing