Fortrea, a leading global contract research organization (CRO), is hiring for the position of Safety Science Analyst in Pune. This is a full-time role that offers an excellent opportunity for candidates with a background in pharmaceuticals, biotechnology, or clinical research to work in the field of clinical safety and pharmacovigilance. The role involves managing and processing adverse event reports, ensuring compliance with regulatory requirements, and supporting safety operations.
Fortrea is a global leader in clinical research and pharmacovigilance services, providing innovative solutions to pharmaceutical, biotechnology, and medical device companies. The company is committed to ensuring the safety and efficacy of medical products through rigorous clinical trials and post-marketing surveillance.
Job Overview
The Safety Science Analyst will assist with Clinical Safety and Pharmacovigilance (PSS) operations, including the management and processing of adverse event reports from clinical trials and post-marketing settings. The role requires ensuring that safety data is processed and submitted to clients, regulatory agencies, and other stakeholders within agreed timelines. The analyst will also ensure compliance with health and safety regulations, including the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3.
Fortrea Safety Science Analyst Job Responsibilities
- Case Intake and Triage: Perform case intake and triage of incoming safety information or reports from various sources, including spontaneous reports and clinical trials.
- Adverse Event Processing: Assist with the processing of adverse events, including data entry, writing patient narratives, and coding adverse events using MedDRA.
- Regulatory Submissions: Assist in the submission of expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, and investigators within agreed timelines.
- Database Reconciliation: Assist in the reconciliation of safety databases as applicable.
- Quality Management: Work within the Quality Management System (QMS) framework, including adherence to Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
- Documentation: Support the maintenance of files and documentation related to adverse event reporting requirements and assist in the archiving of case/study/project documentation.
- Compliance: Ensure compliance with governing regulatory requirements and support the preparation of expedited and periodic reports for regulatory agencies.
- Collaboration: Build and maintain good relationships across functional units and support compliance of operations with regulatory requirements.
Qualifications
Minimum Required:
- Non-Degree with 6 months to 1 year of safety experience* or relevant experience**.
- Associate Degree with 0-6 months of safety experience* or relevant experience**.
- Bachelor’s Degree (BS/BA) with 0-6 months of safety experience* or relevant experience**.
- Master’s Degree (MS/MA) with 0 years of safety experience* or relevant experience**.
- PharmD with 0 years of safety experience* or relevant experience**.
Note:
- Safety Experience* includes processing AE/SAE reports, generating narratives, working within safety databases, and regulatory submissions.
- Relevant Experience** includes experience in pharmaceutical, biotechnology, or CRO industries, such as Medical Affairs, Clinical Data Management, Regulatory Affairs, or Quality Assurance.
Preferred Disciplines:
- Biological Sciences
- Pharmacy
- Nursing
- Medical Sciences
- Life Sciences
- Related fields
Experience and Skills
- Attention to Detail: Strong attention to detail and accuracy in handling safety data.
- Team Player: Ability to work collaboratively in a team environment.
- Communication Skills: Solid written and verbal communication skills.
- Technical Skills: Knowledge of MS Office and Windows applications is beneficial.
- Numerical Skills: Accurate math and spelling skills, with an aptitude for handling and proofreading numerical data.
- Office Equipment: Ability to operate standard office equipment.
Physical Demands and Work Environment
- Work Environment: Office-based or remote work environment.
- Physical Demands: Standard office work with no significant physical demands.
Fortrea Safety Science Analyst Salary
Based on industry standards and the role’s responsibilities, the expected salary for a Safety Science Analyst at Fortrea typically ranges between INR 3.5 LPA to 6 LPA, depending on the candidate’s qualifications, experience, and location.
How to Apply for the Fortrea Safety Science Analyst Jobs?
- Application Deadline: March 22, 2025 (2 days left to apply)
- Job Requisition ID: 251468
- Application Process: Interested candidates can apply through the company’s career portal or follow the application instructions provided in the job posting.
- Direct Application Link: Click Here
Why Join Fortrea?
- Global Exposure: Work with a globally recognized CRO and gain exposure to international regulatory standards.
- Career Growth: Opportunities for professional development and career advancement in the field of clinical safety and pharmacovigilance.
- Work-Life Balance: Flexible work environment with options for remote work.
This is a great opportunity for candidates looking to build a career in clinical safety and pharmacovigilance. If you meet the qualifications and are interested in this role, make sure to apply before the deadline. For more details, visit the official Fortrea career portal.
Disclaimer: The information provided in this article is based on the official job posting by Fortrea. The expected salary is based on industry standards and may vary depending on the candidate’s experience and qualifications. Candidates are advised to refer to the official job posting for accurate and detailed information.
