Pharmacovigilance Executive - Drug Safety & Patent Analysis

Why This Role Matters
The Pharmacovigilance Executive, also known as a Drug Safety Officer, plays a crucial role in monitoring and reporting the safety and effectiveness of pharmaceutical products. By tracking adverse effects, side effects, and drug safety in the general population, hospitals, and clinical trials, this role ensures patient safety and regulatory compliance. The position contributes to improving drug development, clinical research outcomes, and the overall quality of pharmaceutical products in the market.

Job Description
The Pharmacovigilance Executive is responsible for collecting, evaluating, and reporting data on adverse drug reactions and safety concerns. The role involves analyzing safety data from clinical trials and post-marketing studies, coding medical information, and preparing reports for regulatory authorities. The candidate will also undergo a self-financed job-oriented patent analyst training at the Indian Institute of Patent and Trademark. On successful completion, the candidate will transition into a full-time patent analysis or paralegal profile, combining pharmaceutical knowledge with patent research skills.

Key Features Of The Role
• Monitor and report the safety and effectiveness of pharmaceutical products in clinical and post-marketing settings
• Collect, evaluate, and code adverse drug reactions and safety data
• Prepare and submit safety reports to regulatory authorities
• Participate in clinical research studies and pharmacovigilance projects
• Undergo patent analyst training and transition to patent research or paralegal roles
• Collaborate with cross-functional teams including medical affairs, regulatory, and clinical research
• Maintain accurate records of safety data, reports, and correspondence
• Ensure compliance with pharmacovigilance guidelines, SOPs, and regulatory requirements

Responsibilities
• Track adverse events, side effects, and drug safety data from hospitals, clinical trials, and post-marketing surveillance
• Evaluate and code medical information using standard coding systems
• Prepare reports for internal review and submission to regulatory authorities
• Collaborate with medical, regulatory, and research teams to ensure data accuracy and completeness
• Participate in safety audits and quality assurance activities
• Complete patent analyst training at the Indian Institute of Patent and Trademark
• Transition into full-time patent analysis or paralegal responsibilities after training
• Stay updated with pharmacovigilance guidelines, regulations, and best practices
• Support research and development projects through data analysis and reporting

Required Qualifications

Educational Requirements
• UG – B.Pharm in any specialization, BDS in any specialization
• PG – M.Pharm in any specialization

Experience And Skills
• Scientific and analytical thinking
• Knowledge of pharmacovigilance, drug research, and clinical studies
• Familiarity with medical coding, regulatory reporting, and safety documentation
• Understanding of life sciences, physiology, and medical research
• Attention to detail, accuracy, and compliance with regulatory standards
• Good communication and teamwork skills

Salary Insights
• ₹2,00,000 – ₹4,00,000 per annum, depending on experience and skills
• Full-time, permanent employment with opportunities for professional growth
• Exposure to pharmacovigilance, clinical research, and patent analysis

Company Overview
The organization operates in the pharmaceutical and life sciences industry, providing high-quality research, regulatory, and pharmacovigilance services. It focuses on patient safety, regulatory compliance, and scientific rigor, with a commitment to training and developing talent in both pharmacovigilance and patent analysis.

FAQs
Q: What is the initial training program?
A: Candidates will undergo self-financed job-oriented patent analyst training at the Indian Institute of Patent and Trademark.

Q: What career opportunities are available after training?
A: Candidates will transition to full-time roles in patent analysis or paralegal profiles, combining pharmaceutical knowledge with patent research skills.

Q: What skills are required for this role?
A: Pharmacovigilance, drug research, medical coding, life sciences knowledge, and analytical thinking are essential.

Application Tips
• Highlight experience or knowledge in pharmacovigilance, clinical research, and drug safety
• Emphasize analytical thinking and attention to detail
• Showcase familiarity with regulatory reporting and medical coding
• Include any exposure to patent research or interest in patent analysis