Are you passionate about drug safety and regulatory compliance? Fortrea is seeking a dedicated Safety Science Analyst to join our team in Pune, India. In this full-time role, you’ll work within a collaborative and inclusive environment, contributing to the safety and efficacy of medications worldwide.
About Fortrea
At Fortrea, we are dedicated to improving healthcare by delivering top-tier clinical trial solutions and pharmacovigilance services. Our diverse team works together to meet global regulatory standards while fostering a supportive and inclusive workplace.
Key Responsibilities
As a Safety Science Analyst, you will play a pivotal role in handling safety information and adverse events. Your responsibilities include:
Case Intake and Processing
- Collect and triage safety information or reports from various sources, including clinical trials.
- Perform data entry and manage safety data within adverse event tracking systems.
- Write detailed patient narratives and accurately code adverse events using MedDRA.
- Conduct listedness assessments against appropriate labels for marketed products.
Adverse Event Reporting
- Assist in generating queries and collecting missing information, consulting with medical staff as needed.
- Prepare and submit expedited and periodic SAE reports to stakeholders, including clients, regulatory authorities, ethics committees, and investigators, within agreed timelines.
- Manage the reconciliation of databases and ensure compliance with regulatory reporting requirements.
Quality Management and Documentation
- Work within the Quality Management System, adhering to SOPs and Work Instructions.
- Maintain files and documentation related to adverse event reporting requirements.
- Upload and archive case, study, or project-related documents as appropriate.
Cross-Functional Collaboration
- Build and maintain strong relationships across functional units.
- Support compliance with governing regulatory requirements and operational excellence.
Qualifications and Skills
Education and Experience
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
- Prior experience in pharmacovigilance or a similar role is a plus.
Skills
- Proficiency in adverse event data entry and tracking systems.
- Strong understanding of MedDRA coding and safety reporting processes.
- Attention to detail with excellent analytical and communication skills.
- Ability to prioritize tasks and meet regulatory timelines.
