Safety Science Coordinator II at Fortrea
Location: Bangalore
Experience Required: 2 – 5 Years
Salary: ₹5 – 6 LPA
Educational Qualifications: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Life Sciences
Application Type: Online Application Available
Job Type: Verified Job
Fortrea, a globally renowned Contract Research Organization (CRO), is at the forefront of clinical research and therapeutic advancements. Operating in over 90 countries, Fortrea is dedicated to scientific rigor, facilitating patient access, and delivering innovative solutions across the pharmaceutical, biotechnology, and medical device sectors. Safety Science Coordinator II at Fortrea
Job Highlights
- Flexible Work Environment
- Work-Life Balance
- Problem-Solving Opportunities
- Growth and Mentorship
Responsibilities as a Safety Science Coordinator II
As a Safety Science Coordinator II at Fortrea, you will be integral to pharmacovigilance and safety management. Here’s what you’ll be doing: Safety Science Coordinator II at Fortrea
| Responsibility Area | Details |
|---|---|
| Adverse Event Processing | Manage receipt, review, and data entry of adverse events into designated databases, ensuring compliance with regulatory requirements. |
| Case Review | Assess adverse event cases for completeness and accuracy, determine if expedited reporting is necessary. |
| Patient Narratives & Coding | Write detailed patient narratives and code adverse events using MedDRA. |
| Medical Review & Reporting | Ensure proper medical review and prioritize cases for timely regulatory submissions. |
| Report Submission | Prepare and submit Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs) to clients and regulatory bodies. |
| Documentation & Maintenance | Track reporting activities, maintain project files, and ensure accuracy in all documentation. |
| Quality Assurance | Conduct peer reviews, quality checks, and participate in database reconciliation. |
| Training & Mentoring | Assist with onboarding and mentoring new team members as necessary. |
| Compliance & Audit Support | Prepare for client meetings, audits, and ensure audit readiness by maintaining compliant processes. |
Required Qualifications and Skills
Educational Background
- A Bachelor’s or Master’s degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related fields. Safety Science Coordinator II at Fortrea
Work Experience
- 2-5 years in pharmacovigilance or a similar role, with practical knowledge of safety case processing and regulatory reporting.
Essential Skills
| Skill | Details |
|---|---|
| Attention to Detail | Ensure accuracy in processing and documentation of adverse events and other safety data. |
| Technical Competence | Familiarity with MedDRA coding, safety databases, and case tracking systems. |
| Communication Skills | Strong written and verbal communication to prepare narratives and client interactions. |
| Regulatory Knowledge | Understanding of global regulatory requirements in safety reporting and pharmacovigilance. |
| Problem-Solving | Ability to think proactively and resolve challenges in a fast-paced work environment. |
| Collaboration & Mentorship | Work effectively in a team and support junior staff through mentoring and training. |
Why Join Fortrea?
Working at Fortrea means being part of a pioneering CRO committed to transforming healthcare through science and clinical excellence. Here’s what Fortrea offers:
- Career Growth and Mentorship: Opportunities to expand your skills, gain exposure to global regulatory processes, and learn under experienced professionals.
- Work-Life Balance: A flexible and balanced work culture that values employees’ well-being.
- Global Reach and Impact: Collaborate with teams across 90+ countries to bring life-changing treatments to patients worldwide.
Safety Science Coordinator II at Fortrea
How to Apply
Submit your application through the online portal. Fortrea is looking for passionate individuals who are ready to bring their expertise and dedication to a globally respected research organization.
This opportunity not only provides a rewarding role but also a chance to be part of a team that impacts lives through scientific innovation and dedication to healthcare.
Meta Description
Hiring Safety Science Coordinator II at Fortrea in Bangalore with 2-5 years experience, B.Pharm/M.Pharm/Life Sciences degree. Apply now!
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