Safety Science Coordinator I

Overview

Assist with Clinical Safety and/or PSS operations for products, including adverse event processing from clinical trials and/or post-marketing settings. Process expedited adverse events, support submissions, and provide quality service to internal and external clients.

What you'll do

• Assist in processing Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs), and submissions.
• Maintain adverse event tracking systems.
• Set up and maintain project files and central documentation files.
• Assist with reporting ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel within study-specified timelines.
• Log incoming Adverse Event (AE) and Serious Adverse Event (SAE) reports in the departmental tracking application and forward them to the centralized mailbox.
• Enter safety data into adverse event tracking systems.
• Write patient narratives and accurately code adverse events using MedDRA for marketed products, if applicable.
• Assist with listedness assessments against the appropriate label for marketed products, if applicable.
• Generate queries to collect missing or discrepant information in consultation with medical staff, if needed.
• Submit expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, third-party vendors, Partners, and Fortrea project personnel within agreed timelines.
• Assist with peer and quality review of processed reports and support trends and actions as needed.
• Assist with database reconciliation, as applicable.
• Maintain files regarding adverse event reporting requirements in all countries.
• Work within the Quality Management System framework, including Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
• Prepare and support coordination of safety study files for archiving at project completion.
• Arrange and schedule internal and/or external meetings and teleconferences.
• Train and mentor PSS Assistants or peers in their day-to-day activities.
• Build and maintain PSS relationships across functional units.
• Ensure operations comply with governing regulatory requirements and applicable study or project-specific plans.
• Assume responsibility for the quality of processed data.
• Provide administrative support to PSS personnel.
• Perform other duties as needed or assigned.

What you'll need

• One of the following qualification and experience combinations: Non-Degree with 1–2 years of Safety experience or relevant experience; Associate degree with 6 months to 1 year of Safety experience or relevant experience; BS/BA with 0–6 months to 1 year of Safety experience or relevant experience; MS/MA with 0–6 months of Safety experience or relevant experience; or PharmD with 0–6 months of Safety experience or relevant experience.
• For PharmD, a one-year residency or fellowship can be considered relevant experience.
• Degree preferred to be in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or a related area when considered in lieu of experience.
• Safety experience includes actual experience processing AE/SAE reports, generating narratives and queries, working within safety databases, and experience with regulatory submissions.
• Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.
• Relevant and equivalent experience may be considered in lieu of educational requirements.
• Speak English and the local language.
• Write and read English and the local language.
• Be a good team player and offer peer support as needed.
• Be able to set priorities and handle multiple tasks.
• Have attention to detail.
• Have good written and verbal communication skills.
• Have logical and spelling skills, preferably with an aptitude for handling and proofreading numerical data.
• Have good keyboard skills, preferably with knowledge of MS Office and Windows.
• Be able to operate standard office equipment.

Details

• Location: Pune.
• Work environment: Office environment or remote.
• Comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH Regulations 1989, and the EC (European Commission) Directives 1992/3 as documented in the Company's Health and Safety Manual.