Drug Safety Associate

As an Associate or Senior Associate- Pharmacovigilance Global Regulatory Intelligence, you would support safety intelligence and surveillance activities by monitoring public-domain sources, health authority communications, scientific literature, regulatory updates, and safety-related information to identify emerging risks, safety signals, and regulatory trends.

Key Responsibilities

Safety Intelligence & Monitoring

• Monitor global health authority websites, regulatory agencies, and public databases for safety-related updates.
• Track adverse drug reaction communications, recalls, label changes, safety alerts, and risk minimization measures.
• Review scientific literature, conference proceedings, and medical publications for product-specific safety information.
• Conduct routine surveillance of public-domain safety information.
• Surveillance of Health care professional letters, signal evaluation and assessments.

Data Analysis & Reporting

• Analyze safety trends and emerging risks across products, therapeutic areas, and markets.
• Prepare safety intelligence summaries and executive dashboards.
• Identify potential safety signals from publicly available information.
• Support trend analysis using internal and external datasets.

Knowledge Management

• Classify and tag safety-related content.
• Maintain pharmacovigilance knowledge repositories.
• Support metadata management and content categorization.

Required Skills

• Understanding of pharmacovigilance concepts and safety lifecycle.
• Experience reviewing regulatory and safety-related content.
• Strong analytical and research skills.
• Familiarity with MedDRA and safety terminology.
• Familiarity with global regulations in the pharmaceutical and/ or medical device industry is an added advantage
• Ability to coordinate with stakeholders from multiple functions
• Good English communication and interpersonal skills
• A customer-first attitude
• Problem-solving aptitude
• Ability to work well with a team