Assoc I PSS

Overview

Assist with clinical safety and/or PSS operations, including processing adverse event reports from clinical trials and post-marketing (unsolicited) sources, and submitting them to clients and regulatory agencies within agreed timelines.

What you'll do

• Process adverse event reports from any source as per client/sponsor agreed plans.
• Manage receipt and processing of all adverse event reports, spontaneous or from clinical trials.
• Enter safety data onto adverse event databases and tracking systems.
• Review adverse events for completeness, accuracy and appropriateness for expedited reporting.
• Write patient narratives and code adverse events accurately using MedDRA, if applicable.
• Determine lists against the appropriate label (for marketed products, if applicable).
• Identify clinically significant information missing from initial reports and generate queries for its collection, consulting medical staff if needed.
• Ensure cases receive appropriate medical review.
• Prioritize and submit cases requiring expedited reporting within regulatory and/or study-specific timelines.
• Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, third-party vendors, partners and Fortrea project personnel, as agreed during study set-up.
• Process Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) and their submission, including maintaining tracking systems.
• Set up and maintain project files and central files for documentation.
• Assist with reporting of ESRs and PSRs to clients, regulatory authorities, ethics committees, investigators and Fortrea project personnel within study timelines.
• Support quality review or peer review of processed reports.
• Assist and/or complete database reconciliation and associated activities, as applicable.
• Maintain study/project-level documentation as per agreed requirements.
• Support training of PSS staff and mentor the team as needed.
• Support input for monthly status reports and assist in generating and maintaining PSS metrics, if needed.
• Maintain a comprehensive understanding of SOPs, work instructions, guidance documents and directives associated with safety management, reporting and pharmacovigilance.
• Assist in preparing for client meetings and liaise with client contacts where appropriate.
• Assist in quality issues management and support audit and inspection preparation, as needed.
• Ensure operations comply with governing regulatory requirements and applicable study/project plans, and take responsibility for the quality of data processed.
• Perform any other duties as assigned by management.

What you'll need

• Non-degree plus 1 year of safety experience, or 3 years of relevant experience.
• Associate degree plus 1 year of safety experience, or 2 years of relevant experience.
• BS/BA plus 1 year of relevant experience.
• MS/MA plus 1 year of relevant experience.
• PharmD plus 1 year of relevant experience; a one-year residency or fellowship can be considered as relevant experience.
• High degree of accuracy with attention to detail.
• Functions as a team player and offers peer support as needed.
• Good written and verbal communication skills.
• Ability to work independently with moderate supervision.

Nice to have

• Degree preferably in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related area.
• Good keyboard skills with knowledge of MS Office and Windows applications.
• Mentoring skills.

Details

• Location: Bangalore.
• Work environment: office or remote.