Fortrea, a globally recognized leader in clinical research and pharmaceutical services, is seeking a Safety Science Analyst for their Pune, Maharashtra, office. This full-time, on-site role offers a unique opportunity to contribute to Fortrea’s mission of advancing healthcare and delivering impactful solutions.
Company Introduction
Fortrea is dedicated to fostering innovation and excellence in clinical research and safety science. As an Equal Opportunity Employer, the company values diversity, inclusion, and equal opportunities for all. Fortrea maintains a collaborative environment where employees are empowered to thrive professionally while contributing to meaningful advancements in healthcare.
Responsibilities in Job
As a Safety Science Analyst at Fortrea, your key responsibilities will include:
- Case Intake and Triage:
- Manage the intake and triage of safety information from various sources, including spontaneous reports and clinical trials.
- Adverse Event Processing:
- Enter safety data into adverse event tracking systems.
- Draft patient narratives and accurately code adverse events using MedDRA.
- Assist in listedness assessments for marketed products.
- Generate queries and collect missing or discrepant information in consultation with medical staff.
- Submission and Reporting:
- Process and submit expedited SAE reports and periodic safety reports to clients, regulatory bodies, ethics committees, and other stakeholders.
- Prioritize submissions to meet regulatory and study-specific timelines.
- Compliance and Documentation:
- Work within Fortrea’s Quality Management System framework.
- Maintain documentation regarding adverse event reporting requirements.
- Reconcile databases and upload or archive case and project documentation.
- Cross-Functional Collaboration:
- Build and maintain professional relationships across functional units.
- Support compliance with governing regulatory requirements.
- Additional Duties:
- Undertake other tasks as assigned by management.
Qualifications
To excel in this role, candidates must meet the following qualifications:
- Educational Background: A degree in Life Sciences, Pharmacy, or a related field.
- Experience: Prior experience in safety science, pharmacovigilance, or clinical research is highly desirable.
- Technical Proficiency: Familiarity with safety data systems, adverse event coding (e.g., MedDRA), and regulatory requirements.
Skills
Successful candidates will possess:
- Strong attention to detail and analytical skills.
- Excellent written and verbal communication abilities.
- Ability to work collaboratively in cross-functional teams.
- Knowledge of global safety regulations and submission processes.
