Patient Safety Associate

Parexel International (india) Private Limited; Hyderabad; Hybrid; INR 600,000 - 800,000; Full time

Job summary

Parexel International (india) Private Limited is seeking a mid-level Patient Safety Associate II to manage pharmacovigilance case processing, ensure regulatory safety submissions, and support global safety activities. The role involves collaboration with affiliates and adherence to safety data standards.

The candidate should have a Life Sciences or related degree with 4+ years in PV, strong analytical abilities, and proficiency in PV systems and MS Office.

Qualifications

• Basic knowledge of Pharmacovigilance and regulatory reporting.
• Understanding of ICH guidelines and medical terminology.
• Strong analytical and communication skills.
• Proficiency in PV databases and MS Office.

Responsibilities

• Process and manage ICSRs including data entry, case assessment, MedDRA coding, narrative writing, follow-up, reconciliation, and quality checks.
• Support regulatory safety submissions, periodic reports, and compliance tracking to health authorities.
• Conduct literature searches and screening to identify adverse events, safety signals, and reportable cases.
• Coordinate with global affiliates on safety reporting, local compliance requirements, translations, and data exchange.
• Assist with regulatory support activities, product registrations, safety database updates, and regulatory intelligence monitoring.
• Ensure adherence to SOPs, regulatory timelines, quality standards, and client requirements.
• Participate in audits, inspections, process improvements, metrics reporting, and training activities.
• Collaborate with cross-functional teams and support client interactions as required.

Skills

Pharmacovigilance

Safety databases

Analytical skills

MS Office & PV systems

Education

Life Sciences/Pharmacy/Biotechnology degree

Tools

PV systems

MS Office

Job description

Patient Safety Associate II

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Patient Safety Associate II

Key Responsibilities

• Process and manage Individual Case Safety Reports (ICSRs) including data entry, case assessment, MedDRA coding, narrative writing, follow-up, reconciliation, and quality checks.
• Support regulatory safety submissions, periodic reports, and compliance tracking to health authorities.
• Conduct literature searches and screening to identify adverse events, safety signals, and reportable cases.
• Coordinate with global affiliates on safety reporting, local compliance requirements, translations, and data exchange.
• Assist with regulatory support activities, product registrations, safety database updates, and regulatory intelligence monitoring.
• Ensure adherence to SOPs, regulatory timelines, quality standards, and client requirements.
• Participate in audits, inspections, process improvements, metrics reporting, and training activities.
• Collaborate with cross-functional teams and support client interactions as required.

Skills & Qualifications

• Basic knowledge of Pharmacovigilance, drug safety regulations, ICH guidelines, and regulatory reporting.
• Good understanding of medical terminology and safety databases.
• Strong analytical, communication, organizational, and problem-solving skills.
• Proficiency in MS Office and PV systems.

Education & Experience

• Degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Biochemistry, Dentistry, or related field.
• 4+ years of experience in Pharmacovigilance, safety case processing, or regulatory reporting preferred.
• Experience Level Mid Level