Fortrea is a global clinical research organization that stands at the forefront of innovation in the healthcare industry. Known for its commitment to high-quality research and safety practices, Fortrea provides critical support to the pharmaceutical, biotechnology, and medical device sectors. The company is dedicated to fostering a diverse and inclusive environment and values integrity, collaboration, and excellence in every aspect of its work.
Job Overview: Safety Science Analyst
The position of Safety Science Analyst at Fortrea in Pune, Maharashtra, is an on-site, full-time role that plays a crucial part in ensuring the safety and efficacy of pharmaceutical products and clinical trials. This role involves handling incoming safety data, processing adverse events, and preparing reports that adhere to global regulatory requirements.
Key Responsibilities in the Job
As a Safety Science Analyst, your responsibilities will include:
- Case Intake and Triage: Managing and organizing incoming safety reports from various sources, including spontaneous reports and clinical trials.
- Data Processing:
- Entering safety data into adverse event tracking systems.
- Writing detailed patient narratives and coding adverse events using MedDRA (Medical Dictionary for Regulatory Activities) for marketed products when applicable.
- Conducting listedness assessments against the appropriate product label.
- Report Generation:
- Assisting in the creation and submission of expedited Serious Adverse Event (SAE) reports.
- Prioritizing and preparing periodic reports for submission to clients, regulatory authorities, ethics committees, investigators, and Fortrea project teams within specified timelines.
- Database Reconciliation: Supporting data consistency checks across various systems.
- Regulatory Compliance:
- Ensuring all operations align with the Quality Management System, including Standard Operating Procedures (SOPs) and departmental Work Instructions (WIs).
- Uploading and archiving relevant case, study, and project documentation.
- Cross-Functional Collaboration: Maintaining positive relationships with other departments and functional units to support the overall workflow.
- Compliance and Documentation: Staying updated with global adverse event reporting requirements and maintaining related documentation.
- Additional Duties: Performing other tasks as assigned by management.
Qualifications Required
Candidates for the Safety Science Analyst role should meet the following qualifications:
- Educational Background: A degree in life sciences, pharmacy, or a related field.
- Experience: Prior experience in pharmacovigilance, clinical safety, or a related field is preferred.
- Technical Knowledge: Familiarity with data entry systems for adverse event tracking and MedDRA coding.
Essential Skills
The following skills are crucial for excelling in this role:
- Attention to Detail: Accuracy in data entry, narrative writing, and report generation.
- Analytical Thinking: Ability to assess the listedness of adverse events against product labels and to identify discrepancies.
- Collaboration and Communication: Strong interpersonal skills to liaise effectively across teams and with external partners.
- Time Management: Capability to prioritize tasks and manage workload to meet regulatory deadlines.
- Regulatory Knowledge: Understanding of global reporting requirements and compliance protocols.
