Safety Science Coordinator I
Fortrea, a leading global Clinical Research Organization (CRO), is seeking a highly motivated Safety Science Coordinator I to join our team in Pune, India. This is an excellent opportunity for recent graduates in life sciences, pharmacy, or nursing to begin a rewarding career in pharmacovigilance, clinical safety, and drug development. As a Safety Science Coordinator I, you will play a crucial role in assisting with the processing of adverse event reports, maintaining safety databases, and supporting regulatory submissions.
Job Summary
The Safety Science Coordinator I is responsible for supporting the processing, documentation, and reporting of adverse events related to pharmaceutical products. This role requires a strong attention to detail, excellent communication skills, and the ability to work effectively within a team environment. You will be trained and mentored to develop expertise in pharmacovigilance principles and practices.
Responsibilities
- Assist in the processing of Expedited and Periodic Safety Reports (ESRs, PSRs).
- Maintain adverse event tracking systems and ensure accurate safety documentation.
- Perform data entry of safety information into databases, including coding adverse events using MedDRA.
- Draft and review patient narratives based on adverse event reports.
- Perform listedness assessments to determine the expectedness of adverse events.
- Support regulatory submissions by preparing safety data and documentation.
- Participate in the reconciliation of safety databases to ensure data integrity.
- Coordinate with internal teams, clients, and regulatory authorities to facilitate efficient safety reporting.
- Adhere to Good Practices (GxP), Standard Operating Procedures (SOPs), and Quality Management System requirements.
- Potentially mentor junior Patient Safety Science Assistants (PSSAs) and participate in cross-functional meetings.
Requirements
- Education: Bachelor’s degree (B.Sc./B.Pharm.) or Master’s degree (M.Sc./M.Pharm./Pharm.D.) in Life Sciences, Pharmacy, Nursing, or a related field.
- Experience: 0-1 year of experience in pharmacovigilance, clinical safety, clinical data management, or regulatory affairs is preferred but not mandatory.
- Skills:
- Excellent written and verbal communication skills.
- Strong attention to detail and accuracy.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Familiarity with MedDRA coding principles.
- Understanding of adverse event reporting requirements.
- Ability to perform data quality review and identify discrepancies.
- Strong analytical and documentation skills.
- Ability to work effectively as part of a team.
Benefits
- Opportunity to work with a global leader in clinical research and pharmacovigilance.
- Exposure to global regulatory processes and requirements.
- Collaborative and supportive work environment.
- Competitive salary and benefits package.
- Professional development and growth opportunities.
- Be part of a company that is making a difference in the world of healthcare.
How to Apply
If you are a motivated and detail-oriented individual with a passion for patient safety and a desire to build a career in pharmacovigilance, we encourage you to apply. Please submit your resume and cover letter through our online application portal. We look forward to receiving your application.