Patient Safety Associate II

This is a fully remote position, open to applicants in India.

📋 Description

• Manage and process Individual Case Safety Reports (ICSRs), which includes data entry, case evaluation, MedDRA coding, narrative composition, follow-ups, reconciliation, and quality assurance checks.

• Assist with regulatory safety submissions, periodic reporting, and compliance oversight to health authorities.

• Perform literature searches and screenings to identify adverse events, safety signals, and cases that require reporting.

• Collaborate with global affiliates on safety reporting, local compliance needs, translations, and data sharing.

• Provide support for regulatory activities, product registrations, safety database updates, and monitoring of regulatory intelligence.

• Ensure compliance with SOPs, regulatory deadlines, quality standards, and client specifications.

• Engage in audits, inspections, process enhancements, metrics reporting, and training initiatives.

• Work with cross-functional teams and assist in client interactions as needed.

⛳️ Requirements

• Fundamental knowledge of pharmacovigilance, drug safety regulations, ICH guidelines, and regulatory reporting processes.

• Strong grasp of medical terminology and familiarity with safety databases.

• Excellent analytical, communication, organizational, and problem-solving abilities.

• Proficient in MS Office and pharmacovigilance systems.

• A degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Biochemistry, Dentistry, or a related discipline.

• Over 4 years of experience in pharmacovigilance, safety case processing, or regulatory reporting is preferred.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and continuing education.

• A supportive and collaborative work environment.

• Health and wellness benefits including medical, dental, and vision coverage.

• Flexible work arrangements and vacation policies.