Fortrea is a leading global contract research organization (CRO) dedicated to providing comprehensive clinical development and patient access solutions to the life sciences industry. With a commitment to innovation, quality, and compliance, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to bring life-changing therapies to patients worldwide.
At Fortrea, we value diversity, inclusion, and collaboration. Our team of experts works tirelessly to ensure the safety and efficacy of medical products, making a meaningful impact on global health.
Job Description
Fortrea is seeking a highly motivated and detail-oriented Safety Science Coordinator II to join our team in Pune. This role is critical in ensuring the accurate and timely processing of adverse event reports, maintaining compliance with regulatory requirements, and supporting pharmacovigilance activities.
Key Responsibilities:
- Adverse Event Reporting:
- Process adverse event reports from various sources as per client/sponsor agreements.
- Manage the receipt and processing of spontaneous and clinical trial adverse event reports.
- Perform data entry of safety data into adverse event databases and tracking systems.
- Review adverse events for completeness, accuracy, and expedited reporting requirements.
- Medical Review and Compliance:
- Write patient narratives and code adverse events using MedDRA.
- Identify missing clinically significant information and generate queries for collection.
- Ensure cases receive appropriate medical review and are prioritized for expedited reporting.
- Regulatory Submissions:
- Submit expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, and third-party vendors within specified timelines.
- Process and submit Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
- Maintain tracking systems and project files for documentation.
- Quality and Training:
- Support quality review or peer review of processed reports.
- Assist in database reconciliation and associated activities.
- Train and mentor PSS staff as needed.
- Maintain compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), and regulatory guidelines.
- Client and Team Collaboration:
- Assist in preparing for client meetings and liaise with client contacts.
- Support audit and inspection preparation and quality issue management.
- Contribute to monthly status reports and PSS metrics generation.
- Additional Duties:
- Perform other duties as assigned by management to support pharmacovigilance operations.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
- 2-4 years of experience in pharmacovigilance, drug safety, or clinical research.
- Proficiency in MedDRA coding and adverse event database systems.
- Strong understanding of global regulatory requirements for pharmacovigilance.
- Excellent attention to detail, organizational, and communication skills.
- Ability to work independently and collaboratively in a fast-paced environment.
Why Join Fortrea?
- Impactful Work: Contribute to the development of life-saving therapies.
- Career Growth: Opportunities for professional development and advancement.
- Inclusive Culture: A diverse and supportive work environment.
- Global Reach: Be part of a team that operates on a global scale.
