Fresher Hiring Safety Science Analyst at Fortrea
Company Overview:
Fortrea is a globally recognized Contract Research Organization (CRO) dedicated to advancing scientific rigor and clinical development. With a strong presence in over 100 countries, Fortrea collaborates with pharmaceutical, biotechnology, and medical device companies to drive innovation in clinical development, patient access, and technology solutions. Our expertise spans across more than 20 therapeutic areas, ensuring that we contribute meaningfully to improving patient outcomes worldwide. We are committed to maintaining high scientific and ethical standards, making Fortrea an ideal workplace for those passionate about the future of healthcare and clinical research. Fresher Hiring Safety Science Analyst at Fortrea
Job Title: Safety Science Analyst
Company: Fortrea
Experience Level: 0 – 1 Year
Location: Pune, India
Employment Type: Full-time
Educational Qualifications: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, or other Life Sciences-related degrees
Application Mode: Online Application
Posting Date: March 18, 2025
Verified Job Posting
Job Overview
The Safety Science Analyst at Fortrea will play a vital role in monitoring and ensuring the safety and efficacy of both clinical trial and post-marketing pharmaceutical products. This position requires meticulous attention to detail, strong regulatory knowledge, and the ability to process adverse event reports effectively. The selected candidate will contribute to global safety operations, ensuring compliance with regulatory requirements and supporting the overall mission of patient safety. Fresher Hiring Safety Science Analyst at Fortrea
Key Responsibilities
Case Intake and Triage:
- Receive, evaluate, and categorize safety information from various sources, including clinical trials and post-marketing surveillance.
- Perform initial assessment of adverse events (AEs) and serious adverse events (SAEs).
- Ensure accurate and timely processing of safety data for further evaluation.
Adverse Event Processing:
- Enter safety-related data into tracking and regulatory databases.
- Prepare patient narratives and accurately code adverse events using MedDRA (Medical Dictionary for Regulatory Activities).
- Perform listedness assessments, determining the relation of reported adverse events to known side effects of the product.
- Fresher Hiring Safety Science Analyst at Fortrea
Regulatory Submissions:
- Compile and submit expedited serious adverse event (SAE) reports to regulatory agencies, ethics committees, and clients within specified timelines.
- Assist in the preparation, review, and submission of periodic safety update reports (PSURs) and development safety update reports (DSURs).
- Maintain documentation and records for regulatory inspections and audits.
- Fresher Hiring Safety Science Analyst at Fortrea
Quality Assurance and Compliance:
- Adhere to Fortrea’s Quality Management System (QMS), Standard Operating Procedures (SOPs), and global regulatory guidelines.
- Ensure compliance with international pharmacovigilance regulations such as ICH-GCP, FDA, EMA, and local authorities.
- Conduct internal audits to ensure safety data accuracy and completeness.
Collaboration and Database Management:
- Work closely with the Pharmacovigilance and Safety Science (PSS) team to facilitate case reconciliation.
- Assist in maintaining and updating safety databases to ensure high-quality data management.
- Provide support in the archival of case-related and study documentation as per regulatory requirements.
- Fresher Hiring Safety Science Analyst at Fortrea
Required Qualifications and Skills
- Educational Background: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related field.
- Work Experience: 0 – 1 year of experience in pharmacovigilance, clinical research, drug safety, or related areas (freshers with relevant qualifications are encouraged to apply).
- Technical Skills:
- Familiarity with MedDRA coding and adverse event tracking systems.
- Knowledge of global regulatory requirements related to pharmacovigilance.
- Experience in medical writing and safety report preparation is a plus.
- Soft Skills:
- Exceptional attention to detail and accuracy.
- Strong organizational and time-management skills.
- Ability to work under tight deadlines and manage multiple priorities efficiently.
- Excellent verbal and written communication skills.
- Ability to collaborate effectively with cross-functional teams.
Work Environment & Benefits
- Work-Life Balance: Fortrea promotes a balanced work environment, offering flexible schedules and time management support.
- Career Growth: Opportunities for professional development and training in pharmacovigilance and safety science.
- Challenging Projects: Work on cutting-edge clinical research and safety initiatives.
- Employee Benefits: Comprehensive health insurance, wellness programs, and performance-based incentives.
- Collaborative Culture: A supportive and inclusive workplace with opportunities to work alongside industry experts.
- Fresher Hiring Safety Science Analyst at Fortrea
How to Apply
Interested candidates can apply online by submitting their updated resumes through Fortrea’s official career portal. Early applications are encouraged as screening will be conducted on a rolling basis.
About Fortrea:
At Fortrea, we are dedicated to shaping the future of clinical research. Our expertise in safety science and pharmacovigilance ensures that innovative therapies reach patients safely and efficiently. If you are passionate about patient safety and regulatory excellence, we invite you to join our dynamic team and contribute to groundbreaking healthcare solutions. Fresher Hiring Safety Science Analyst at Fortrea
Apply Today & Kickstart Your Career in Pharmacovigilance!
