Senior Safety Associate, 3 - 6 years exp, Hyderabad / Secunderabad

Review serious adverse experience (SAE) information received from Investigator sites and adverse experiences (AEs) from post marketing sources for completeness and regulatory compliance

Perform quality control review of completed individual and periodic safety reports and ensure compliance with regulatory reporting requirements

Prepare safety data reports for submissions to clients

Prepare and/or review expedited Safety Reports for submission to Regulatory Authorities

Communicate with Clinical Operations and clients to ensure compliance with safety and Pharmacovigilance SOPs

Prepare regulatory submissions, i.e., Annual Reports, Periodic Safety Update Reports

Be the safety lead for projects; to include set-up, project management, client liaison

Prepare SAE reporting plans

Mentor Safety Associates and other members to the Global Safety and Pharmacovigilance group involved in safety data processing

Be responsible for SAE reconciliation for a study

Maintain current knowledge of all applicable FDA/ICH guidelines and regulations relating to safety and Pharmacovigilance reporting

Salary: Not Disclosed by Recruiter

Industry: Pharma / Biotech / Clinical Research

Functional Area: Other

Role Category: Other

Role: Other

Keyskills: Drug Safety, Pharmacovigilance, ARGUS, ARISG, Safety reports, Case Processing