Are you a skilled professional in pharmacovigilance and drug safety? Fortrea is excited to announce a job opportunity for the role of Safety Science Specialist in Pune. This is a full-time position with an application deadline of May 4, 2025. If you have a passion for ensuring drug safety and compliance, this could be the perfect role for you. Read on to learn more about the responsibilities, qualifications, and how to apply.
Job Overview
As a Safety Science Specialist, you will play a critical role in managing adverse event reports, ensuring compliance with regulatory requirements, and maintaining the highest standards of pharmacovigilance. This position offers an excellent opportunity to work in a dynamic environment, contributing to the safety and efficacy of pharmaceutical products.
Key Responsibilities
- Adverse Event Management: Receive, process, and review adverse event reports from clinical trials and other sources. Ensure data accuracy and completeness for expedited reporting.
- Data Entry and Coding: Enter safety data into adverse event databases and code events using MedDRA. Write patient narratives and determine listedness against product labels.
- Regulatory Compliance: Prepare and submit expedited Serious Adverse Event (SAE) reports to regulatory authorities, ethics committees, and other stakeholders within specified timelines.
- Database Reconciliation: Collaborate with Data Management teams to ensure accurate database reconciliation.
- Reporting: Assist in the preparation and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Quality Assurance: Perform quality reviews of processed reports, identify trends, and support root cause analysis for quality issues.
- Documentation: Maintain project files, tracking systems, and ensure proper archiving of safety study files.
- Client Interaction: Support client meetings, provide data for Safety Committees/DSMBs, and liaise with clients as needed.
- Compliance: Stay updated on Standard Operating Procedures (SOPs), Work Instructions (WI), and pharmacovigilance guidelines.
Qualifications and Skills
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
- Proven experience in pharmacovigilance, drug safety, or a similar role.
- Strong knowledge of MedDRA coding and regulatory reporting requirements.
- Excellent attention to detail and ability to manage multiple tasks efficiently.
- Strong communication and interpersonal skills for client interactions.
- Familiarity with safety databases and tracking systems.
- Understanding of ICH-GCP guidelines and global pharmacovigilance regulations.
