Patient Safety Associate II
Primary Location: India, Remote Job ID R0000044642 Category Medical Affairs
About this Role
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.
#LI-REMOTE
JOBS FOR YOU
There is no jobs to view
You currently have no saved jobs to view.
Make sure to accept the Functional cookies to enable this module to display saved job links. You will be able to review them here when you revisit this page..
More Than A Job
