Analyst - Regulatory Intelligence

Analyst - Regulatory Intelligence

IQVIA Regulatory Intelligence provides instant access to regulatory insights and real-time updates from national authorities across the globe, helping you to avoid the resource-intensive process of gathering, organizing, and sharing important regulatory information. IQVIA Regulatory Intelligence services cover more than 110 countries, regions, and international organizations. IQVIA RI supports pharmaceutical and medical device companies by providing access to up-to-date and comprehensive original and translated regulatory documents, expert country summaries, tabulated comparative regulatory information covering operational details and timely alerts with state-of-the-art functionality.

OVERVIEW OF ROLE – SAFETY PROFILE

Based in our India office (Bangalore / Gurgaon), we seek a skilled Individual contributor proficient in applying subject matter expertise. The successful candidate will be responsible for the creation and upkeep of high-quality regulatory intelligence content focusing on Drug Safety & Pharmacovigilance. Knowledge on Device Safety will be an added advantage. Responsibilities also include managing day-to-day operations for IQVIA Regulatory Intelligence, covering planning, client delivery, and maintaining quality standards.

RESPONSIBILITIES

• Prepares, reviews, and updates regulatory documentation in Drug Safety & Pharmacovigilance based on documents published by regulatory authorities as appropriate with particular focus on APAC region, USA, and Canada.
• Monitoring and analysis of regulatory updates (including laws, guidelines, technical requirements, and trends) issued by relevant regulatory bodies in the territory.
• Works within cross-functional teams and collaborates with a network of internal/external regulatory experts to ensure the production and maintenance of high-quality (timeliness, completeness, and accuracy) regulatory intelligence related to clinical trials, as per defined quality processes.
• Performs quality control activities of external expert contributions within the area of clinical trials.
• Provides knowledge related to safety to support inquiries from customers, sales, marketing, and business development.
• Acts as a subject matter expert of Regulatory knowledge in Drug Safety as applicable.
• Understands the scope of work, deliverables, and manages workload as appropriate.
• May give guidance to colleagues and may assist in their training and development.
• May conduct and present regulatory training sessions for small groups or individuals within the RI team.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Proven experience and tenures working in managing Drug Safety submissions within Life Sciences (within regulatory authority, consultancy, or industry) in the USA, Canada and APAC region.
• Preferred hands-on experience in drug safety submissions like ICSR and periodic submissions, RMP, Signal, Literature review in the USA, Canada and APAC region.
• Master’s degree in pharmacy/life sciences.
• In-depth knowledge of Drug Safety & Pharmacovigilance regulations including:
  • Individual case safety report timeline & submissions to regulatory agencies and ethics committees
  • Periodic adverse event report timeline & submissions to regulatory agencies and ethics committees
  • Knowledge about Risk Management Plans, Signal Detection & Literature Review
• Ability to assess impact of new regulatory requirements.
• Ability to understand and interpret regulatory developments (guidelines, regulations, and laws) to understand, anticipate, interpret, and communicate regulatory trends and requirements.
• At least 3-4 years relevant experience.
• Ability to communicate clearly and effectively (verbally and written) and experience in writing summaries/reports for different audiences.
• Strong attention to detail, proactive and highly organized.
• Knowledge of quality management within Life Sciences.
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
• Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable.
• Leverage approved AI tools (e.g., Copilot or equivalent platforms) to support regulatory intelligence activities such as document summarization, trend identification, AI Prompting and draft content generation will be an added advantage.
• Demonstrates self-motivation and enthusiasm.
• Ability to work on several projects, with direction from senior staff as appropriate.
• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements.
• Ability to adapt quickly to a rapidly changing environment. 

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Experience Level

Mid Level