Are you a dedicated pharmacovigilance professional looking to make a meaningful impact in clinical research? Fortrea, a leading global contract research organization (CRO), invites applications for the position of Safety Science Specialist in Bangalore. This is a full-time opportunity to join an innovative team that supports the swift and efficient development of life-changing therapies.
About Fortrea
Fortrea stands at the forefront of clinical research, offering extensive clinical development, patient access, and technology solutions. With operations in over 90 countries and a diverse team of more than 19,000 employees, Fortrea serves pharmaceutical, biotechnology, and medical device clients across 20+ therapeutic areas. Driven by scientific excellence, Fortrea is reshaping drug and device development to benefit both partners and patients around the globe.
Job Responsibilities
As a Safety Science Specialist, you will play a critical role in ensuring that adverse event reports and related safety information are processed in accordance with global regulatory requirements and project timelines. Key responsibilities include:
- Adverse Event Management: Oversee the receipt, processing, and data entry of spontaneous and solicited adverse event reports into safety databases.
- Quality Assurance: Review reports for completeness and accuracy, ensuring readiness for expedited reporting.
- Patient Narratives and Coding: Write patient narratives, accurately code adverse events using MedDRA, and evaluate listedness against appropriate product labels.
- Follow-Up: Identify missing information, coordinate follow-up collection, and consult with medical staff as needed.
- Medical Review: Ensure cases undergo proper medical evaluation.
- Regulatory Reporting: Expedite reporting of adverse events to global regulatory authorities, ethics committees, investigators, and project partners.
- Periodic Reports: Support the creation and submission of Periodic Safety Reports (PSRs) and Expedited Safety Reports (ESRs).
- Documentation and Tracking: Maintain comprehensive project files and tracking systems for adverse event reporting.
- Peer Reviews and Quality Checks: Conduct quality and peer reviews of reports and contribute to process improvements.
- Support for Audits and Inspections: Assist in preparing for and participating in audits and inspections.
- Cross-Functional Collaboration: Collaborate with internal teams and clients to support project deliverables and client interactions.
Qualifications and Experience
- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- Experience: Minimum of 3+ years in pharmacovigilance, with specific experience in clinical trial case processing.
- Skills: Strong knowledge of clinical safety regulations and ICH guidelines, excellent attention to detail, and effective communication abilities.
Core Competencies
- Demonstrated understanding of safety data management and pharmacovigilance SOPs.
- Experience with database reconciliation and SAE/ESR processing.
- Proficiency in safety reporting and supporting safety committees.
- Ability to engage in root cause analysis and contribute to CAPA plan development.
